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A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (SPECTRI)

Primary Purpose

Geographic Atrophy

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lampalizumab
Sham Comparator
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants aged greater than or equal to (>/=) 50 years
  • Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Exclusion Criteria:

Ocular Exclusion Criteria (Study Eye):

  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  • Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
  • Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation)

Ocular Exclusion Criteria (Both Eyes):

  • GA in either eye due to causes other than AMD
  • Previous treatment with eculizumab, lampalizumab, and/or fenretinide

Sites / Locations

  • Associated Retina Consultants
  • Retina Associates Southwest PC
  • Retina Consultants of Orange County
  • UCSD Shiley Eye Center
  • Jules Stein Eye Institute/ UCLA
  • N CA Retina Vitreous Assoc
  • Byers Eye Insitute at Stanford
  • Retina Consultants, San Diego
  • University of California, Davis, Eye Center
  • Retinal Consultants Med Group
  • California Retina Consultants
  • Bay Area Retina Associates
  • University of Colorado
  • Retina Consultants of Southern
  • Colorado Retina Associates, PC
  • New England Retina Associates
  • Retina Group of New England
  • Retina Group of Florida
  • Retina Health Center
  • Bascom Palmer Eye Institute
  • Retina Vitreous Assoc of FL
  • Southern Vitreoretinal Assoc
  • University of South Florida
  • Emory University
  • Wolfe Eye Clinic
  • Vitreo Retinal Consultants
  • Paducah Retinal Center
  • The Retina Care Center
  • Wilmer Eye Institute
  • Retina Group of Washington
  • Retina Specialists
  • Mass Eye and Ear Infirmary
  • University of Michigan, Kellogg Eye Center
  • Kresge Eye Institute
  • Vitreoretinal Surgery
  • Midwest Vision Research Foundation
  • UNMC Truhlsen Eye Institute
  • Sierra Eye Associates
  • Mid Atlantic Retina - Wills Eye Hospital
  • Retinal & Ophthalmic Cons PC
  • Retina Associates of NJ
  • New York Weil Cornell Med Ctr
  • Vitreous-Retina-Macula
  • Retina Assoc of Western NY
  • Western Carolina Retinal Associate PA
  • Char Eye Ear &Throat Assoc
  • Duke University Eye Center; Vitreoretinal
  • Cincinnati Eye Institute
  • OSU Eye Physicians & Surgeons
  • Retina & Vitreous Center of Southern Oregon
  • Retina Northwest
  • Oregon HSU; Casey Eye Institute
  • Mid Atlantic Retina
  • Allegheny Ophthalmic & Orbital
  • MUSC Storm eye institute
  • Palmetto Retina Center
  • Charleston Neuroscience Inst
  • Black Hills Eye Institute
  • Southeastern Retina Associates Chattanooga
  • Charles Retina Institution
  • Retina Res Institute of Texas
  • Texas Retina Associates
  • Retina Consultants of Houston
  • Scott and White Hospital
  • Retina Consultants of Houston
  • Univ of Virginia Ophthalmology
  • Vitreoretinal Associates of Washington
  • Oftalmos
  • Instituto de la Vision
  • Hospital El Cruce
  • Queensland Eye Institute
  • Adelaide Eye and Retina Centre
  • Vision Eye Institute Eastern
  • Royal Victorian Eye and Ear Hospital
  • The Lions Eye Institute
  • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
  • CHU Brugmann (Victor Horta)
  • UZ Leuven Sint Rafael
  • Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37
  • Hopital Pellegrin; Ophtalmologie
  • CHU Bocage; Ophtalmologie
  • Hopital de la croix rousse; Ophtalmologie
  • Centre Paradis Monticelli; Ophtalmologie
  • Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique
  • CHNO des Quinze Vingts; Ophtalmologie
  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
  • Universitätsklinik Heidelberg; Augenklinik
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
  • LMU Klinikum der Universität, Augenklinik
  • Klinikum rechts der Isar der TU München; Augenklinik
  • Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
  • Universitätsklinikum Tübingen
  • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
  • Semmelweis Egyetem AOK, Szemeszeti Klinika
  • Ganglion Medial Center
  • UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
  • Irccs Ospedale San Raffaele;U.O. Oculistica
  • ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
  • A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico
  • Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
  • Hospital Nuestra Señora de La Luz
  • Hospital Universitario de Monterrey
  • Instituto Mexicano de Oftalmologia I.A.P.
  • Radboud University Nijmegen Medical Centre; Ophthalmology
  • Erasmus Medisch Centrum
  • Mácula D&T
  • TG Laser Oftalmica
  • Centro de Investigacion Oftalmolaser
  • OFTALMIKA Sp. z o.o
  • Szpital Specjalistyczny nr 1; Oddzial Okulistyki
  • Uniwersytecki Szpital Kliniczny; Klinika Okulistyki
  • Klinika Okulistyczna Jasne Błonia
  • AIBILI - Association for Innovation and Biomedical Research on Light
  • Espaco Medico Coimbra
  • Hospital de Santa Maria; Servico de Oftalmologia
  • Hospital de Sao Joao; Servico de Oftalmologia
  • SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic"
  • FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences
  • St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology
  • FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU
  • Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB
  • Instituto Oftalmologico Gomez Ulla
  • Clinica Universitaria de Navarra; Servicio de Oftalmologia
  • Hospital Perpetuo Socorro; Servicio de Oftalmología
  • Instituto de microcirugia ocular
  • VISSUM Madrid Santa Hortensia
  • Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia
  • Hospital Universitario la Fe: Servicio de Oftalmologia
  • St Eriks Eye Hospital
  • Inselspital Bern, Universitätsklinik für Augenheilkunde
  • Vista Klinik Binningen
  • Hacettepe University Medical Faculty; Department of Ophthalmology
  • Ankara University Medical Faculty; Department of Ophthalmology
  • Ankara Baskent University Medical Faculty; Department of Ophthalmology
  • Istanbul University Istanbul Medical Faculty; Department of Ophthalmology
  • Ege University Medical Faculty; Department of Ophthalmology
  • Dokuz Eylul University Medical Faculty; Department of Ophthalmology
  • Royal Victoria Hospital
  • Bradford Royal Infirmary
  • Bristol Eye Hospital
  • University Hospital of Wales
  • Gloucestershire Hospitals NHS Foundation Trust
  • Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
  • Moorfields Eye Hospital NHS Foundation Trust
  • Kings College Hospital
  • Macular Treatment Centre; Royal Eye Hospital
  • Hillingdon Hospital
  • Royal Victoria Infirmary
  • Southampton General Hospital
  • The Royal Wolverhampton Hospitals NHS Trust
  • The York Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Lampalizumab once in every 4 weeks (Q4W)

Lampalizumab once in every 6 weeks (Q6W)

Sham Comparator

Arm Description

Participants will receive 10 mg (milligrams) dose of lampalizumab by intravitreal injection, Q4W, starting at the Day 1 visit for approximately 92 weeks.

Participants will receive 10 mg dose of lampalizumab by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.

Participants will receive sham comparator, Q4W, starting at the Day 1 visit for approximately 92 weeks or Q6W, starting at the Day 1 visit for approximately 90 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).

Secondary Outcome Measures

Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48
Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48
Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48
BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening.
Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48
Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48
The low luminance visual acuity was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. A negative change from baseline indicates a decrease in the visual acuity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48
Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48
MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48
MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48
NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health, general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale or total score is the average of items contributing to the score. For each subscale and total score the score range is 0 to 100 with a higher score representing better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48
NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48
NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48
The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.

Full Information

First Posted
July 15, 2014
Last Updated
October 14, 2019
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02247531
Brief Title
A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Acronym
SPECTRI
Official Title
A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Study Start Date
October 6, 2014 (Actual)
Primary Completion Date
January 23, 2018 (Actual)
Study Completion Date
January 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
975 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lampalizumab once in every 4 weeks (Q4W)
Arm Type
Experimental
Arm Description
Participants will receive 10 mg (milligrams) dose of lampalizumab by intravitreal injection, Q4W, starting at the Day 1 visit for approximately 92 weeks.
Arm Title
Lampalizumab once in every 6 weeks (Q6W)
Arm Type
Experimental
Arm Description
Participants will receive 10 mg dose of lampalizumab by intravitreal injection, Q6W, starting at the Day 1 visit for approximately 90 weeks.
Arm Title
Sham Comparator
Arm Type
Sham Comparator
Arm Description
Participants will receive sham comparator, Q4W, starting at the Day 1 visit for approximately 92 weeks or Q6W, starting at the Day 1 visit for approximately 90 weeks.
Intervention Type
Drug
Intervention Name(s)
Lampalizumab
Other Intervention Name(s)
RO5490249
Intervention Description
10 mg dose of lampalizumab administered intravitreally.
Intervention Type
Other
Intervention Name(s)
Sham Comparator
Intervention Description
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
Primary Outcome Measure Information:
Title
Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
Description
The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Time Frame
Baseline, Week 48
Title
Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
Description
For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
Time Frame
Baseline, Week 48
Secondary Outcome Measure Information:
Title
Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48
Description
Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame
Baseline, Week 48
Title
Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48
Description
Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame
Baseline, Week 48
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48
Description
BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening.
Time Frame
Baseline, Week 48
Title
Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48
Description
Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame
Week 48
Title
Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48
Description
The low luminance visual acuity was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. A negative change from baseline indicates a decrease in the visual acuity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame
Baseline, Week 48
Title
Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48
Description
Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame
Week 48
Title
Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48
Description
MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame
Baseline, Week 48
Title
Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48
Description
MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame
Baseline, Week 48
Title
Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48
Description
NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health, general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale or total score is the average of items contributing to the score. For each subscale and total score the score range is 0 to 100 with a higher score representing better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame
Baseline, Week 48
Title
Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48
Description
NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame
Baseline, Week 48
Title
Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48
Description
NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame
Baseline, Week 48
Title
Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48
Description
The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
Time Frame
Baseline, Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants aged greater than or equal to (>/=) 50 years Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes Exclusion Criteria: Ocular Exclusion Criteria (Study Eye): History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular Exclusion Criteria (Both Eyes): GA in either eye due to causes other than AMD Previous treatment with eculizumab, lampalizumab, and/or fenretinide
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Associated Retina Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Retina Associates Southwest PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85750
Country
United States
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
UCSD Shiley Eye Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0946
Country
United States
Facility Name
Jules Stein Eye Institute/ UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7000
Country
United States
Facility Name
N CA Retina Vitreous Assoc
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Byers Eye Insitute at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Retina Consultants, San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
University of California, Davis, Eye Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Retinal Consultants Med Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95841
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Retina Consultants of Southern
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Colorado Retina Associates, PC
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
New England Retina Associates
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Retina Group of New England
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06385
Country
United States
Facility Name
Retina Group of Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Retina Health Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Naples
State/Province
Florida
ZIP/Postal Code
34103
Country
United States
Facility Name
Retina Vitreous Assoc of FL
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Southern Vitreoretinal Assoc
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Vitreo Retinal Consultants
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Paducah Retinal Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
The Retina Care Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Retina Group of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Retina Specialists
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Mass Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan, Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Kresge Eye Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1423
Country
United States
Facility Name
Vitreoretinal Surgery
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Midwest Vision Research Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
UNMC Truhlsen Eye Institute
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Mid Atlantic Retina - Wills Eye Hospital
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
Retinal & Ophthalmic Cons PC
City
Northfield
State/Province
New Jersey
ZIP/Postal Code
08225
Country
United States
Facility Name
Retina Associates of NJ
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
New York Weil Cornell Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Vitreous-Retina-Macula
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Retina Assoc of Western NY
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Western Carolina Retinal Associate PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Char Eye Ear &Throat Assoc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Duke University Eye Center; Vitreoretinal
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
OSU Eye Physicians & Surgeons
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Retina & Vitreous Center of Southern Oregon
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Retina Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97221
Country
United States
Facility Name
Oregon HSU; Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Mid Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny Ophthalmic & Orbital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
MUSC Storm eye institute
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Palmetto Retina Center
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Charleston Neuroscience Inst
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Black Hills Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Southeastern Retina Associates Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Charles Retina Institution
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Retina Res Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Univ of Virginia Ophthalmology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Vitreoretinal Associates of Washington
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Oftalmos
City
Capital Federal
ZIP/Postal Code
C1120AAN
Country
Argentina
Facility Name
Instituto de la Vision
City
Capital Federal
ZIP/Postal Code
C1122AAI
Country
Argentina
Facility Name
Hospital El Cruce
City
Florencio Varela
ZIP/Postal Code
B1888AAE
Country
Argentina
Facility Name
Queensland Eye Institute
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Adelaide Eye and Retina Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Vision Eye Institute Eastern
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Royal Victorian Eye and Ear Hospital
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
The Lions Eye Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
CHU Brugmann (Victor Horta)
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
UZ Leuven Sint Rafael
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Hopital Pellegrin; Ophtalmologie
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU Bocage; Ophtalmologie
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital de la croix rousse; Ophtalmologie
City
Lyon cedex
ZIP/Postal Code
69317
Country
France
Facility Name
Centre Paradis Monticelli; Ophtalmologie
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Hopital Hotel Dieu Et Hme; Clinique Ophtalmologique
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHNO des Quinze Vingts; Ophtalmologie
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinik Heidelberg; Augenklinik
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
LMU Klinikum der Universität, Augenklinik
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München; Augenklinik
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Semmelweis Egyetem AOK, Szemeszeti Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Ganglion Medial Center
City
Pécs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Irccs Ospedale San Raffaele;U.O. Oculistica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Facility Name
A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10122
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
City
Udine
State/Province
Veneto
ZIP/Postal Code
33100
Country
Italy
Facility Name
Hospital Nuestra Señora de La Luz
City
Mexico City
ZIP/Postal Code
06030
Country
Mexico
Facility Name
Hospital Universitario de Monterrey
City
Monterrey
ZIP/Postal Code
64040
Country
Mexico
Facility Name
Instituto Mexicano de Oftalmologia I.A.P.
City
Querétaro
ZIP/Postal Code
76090
Country
Mexico
Facility Name
Radboud University Nijmegen Medical Centre; Ophthalmology
City
Nijmegen
ZIP/Postal Code
6525 EX
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Mácula D&T
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
TG Laser Oftalmica
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Centro de Investigacion Oftalmolaser
City
Lima
ZIP/Postal Code
33
Country
Peru
Facility Name
OFTALMIKA Sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Facility Name
Szpital Specjalistyczny nr 1; Oddzial Okulistyki
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny; Klinika Okulistyki
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Klinika Okulistyczna Jasne Błonia
City
Łódź
ZIP/Postal Code
91-134
Country
Poland
Facility Name
AIBILI - Association for Innovation and Biomedical Research on Light
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
Facility Name
Espaco Medico Coimbra
City
Coimbra
ZIP/Postal Code
3030-163
Country
Portugal
Facility Name
Hospital de Santa Maria; Servico de Oftalmologia
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital de Sao Joao; Servico de Oftalmologia
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
SAHI "Republic clinical ophthalmological hospial of Ministry of Heal of Tatarstan Republic"
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology
City
Samara
ZIP/Postal Code
443068
Country
Russian Federation
Facility Name
FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
Facility Name
Instituto Oftalmologico Gomez Ulla
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Oftalmologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Perpetuo Socorro; Servicio de Oftalmología
City
Albacete
ZIP/Postal Code
02006
Country
Spain
Facility Name
Instituto de microcirugia ocular
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
VISSUM Madrid Santa Hortensia
City
Madrid
ZIP/Postal Code
28002
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Oftalmologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario la Fe: Servicio de Oftalmologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
St Eriks Eye Hospital
City
Stockholm
ZIP/Postal Code
SE-112 82
Country
Sweden
Facility Name
Inselspital Bern, Universitätsklinik für Augenheilkunde
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Vista Klinik Binningen
City
Binningen
ZIP/Postal Code
4102
Country
Switzerland
Facility Name
Hacettepe University Medical Faculty; Department of Ophthalmology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara University Medical Faculty; Department of Ophthalmology
City
Ankara
ZIP/Postal Code
06340
Country
Turkey
Facility Name
Ankara Baskent University Medical Faculty; Department of Ophthalmology
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty; Department of Ophthalmology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Ege University Medical Faculty; Department of Ophthalmology
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dokuz Eylul University Medical Faculty; Department of Ophthalmology
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Bristol Eye Hospital
City
Bristol
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Gloucestershire Hospitals NHS Foundation Trust
City
Gloucestershire
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Macular Treatment Centre; Royal Eye Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Hillingdon Hospital
City
Middx
ZIP/Postal Code
UB8 3NN
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
The Royal Wolverhampton Hospitals NHS Trust
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
The York Hospital
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32199866
Citation
Heier JS, Pieramici D, Chakravarthy U, Patel SS, Gupta S, Lotery A, Lad EM, Silverman D, Henry EC, Anderesi M, Tschosik EA, Gray S, Ferrara D, Guymer R; Chroma and Spectri Study Investigators. Visual Function Decline Resulting from Geographic Atrophy: Results from the Chroma and Spectri Phase 3 Trials. Ophthalmol Retina. 2020 Jul;4(7):673-688. doi: 10.1016/j.oret.2020.01.019. Epub 2020 Jan 31.
Results Reference
derived
PubMed Identifier
29801123
Citation
Holz FG, Sadda SR, Busbee B, Chew EY, Mitchell P, Tufail A, Brittain C, Ferrara D, Gray S, Honigberg L, Martin J, Tong B, Ehrlich JS, Bressler NM; Chroma and Spectri Study Investigators. Efficacy and Safety of Lampalizumab for Geographic Atrophy Due to Age-Related Macular Degeneration: Chroma and Spectri Phase 3 Randomized Clinical Trials. JAMA Ophthalmol. 2018 Jun 1;136(6):666-677. doi: 10.1001/jamaophthalmol.2018.1544.
Results Reference
derived

Learn more about this trial

A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

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