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

Primary Purpose

Geographic Atrophy

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lampalizumab
Sham
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:

  • 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 (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

  • Uni of Alabama At Birmingham Clinical Research Unit
  • Retinal Research Institute, LLC
  • Retina Centers P.C.
  • California Retina Consultants
  • Retina-Vitreous Associates Medical Group
  • The Gavin Herbert Eye Institute - UC, Irvine
  • Jules Stein Eye Institute/ UCLA
  • East Bay Retina Consultants
  • Southern CA Desert Retina Cons
  • W Coast Retina Med Group Inc
  • UCSF; Ophthalmology
  • Orange County Retina Med Group
  • California Retina Consultants
  • Florida Eye Microsurgical Inst
  • National Ophthalmic Research Institute
  • Florida Eye Associates
  • Retina Care Specialists
  • Bascom Palmer Eye Institute
  • Retina Specialty Institute
  • Fort Lauderdale Eye Institute
  • Retina Vitreous Assoc of FL
  • Southern Vitreoretinal Assoc
  • Retina Associates of Florida, LLC
  • Southeast Retina Center
  • Georgia Retina PC
  • Retina Consultants of Hawaii
  • Northwestern Medical Group/Northwestern University
  • University Retina and Macula Associates, PC
  • Midwest Eye Institute Northside
  • Wolfe Eye Clinic
  • Retina Associates
  • Lahey Clinic Med Ctr
  • Retina Associates of Kentucky
  • Maine Eye Center
  • Retina Specialists
  • Tufts Medical Center Research
  • Ophthalmic Consultants of Boston
  • Vitreo-Retinal Associates, PC
  • Vitreo-Retinal Associates
  • Specialty Eye Institute
  • Assoc Retinal Consultants PC
  • Retina Consultants of Michigan
  • Eye Surgical Associates
  • Retina Consultants of Nevada
  • Retina Center of New Jersey
  • New Jersey Retina Research Foundation
  • Delaware Valley Retina Assoc
  • Long Is. Vitreoretinal Consult
  • Opthalmic Consultants of LI
  • New York Eye & Ear Infirmary
  • Retina Consultants of Western New York
  • Retina Vit Surgeons/Central NY
  • Western Carolina Retinal Associate PA
  • Wake Forest Baptist Health Eye Centre
  • Retina Assoc of Cleveland Inc
  • Cleveland Clinic Foundation; Cole Eye Institute
  • Retina Vitreous Consultants
  • Associates in Ophthalmology
  • Charleston Neuroscience Inst
  • Tennessee Retina PC.
  • Vanderbilt
  • Retina Res Institute of Texas
  • Texas Retina Associates
  • Austin Retina Associates
  • Retina Research Center
  • UT Southwestern MC at Dallas
  • Valley Retina Institute P.A.
  • Strategic Clinical Research Group, LLC
  • Retina Associates of Utah
  • Eye Surgeons of Richmond Inc. dba Virginia Eye Institute
  • Retina Institute of Virginia
  • Virginia Retina Center
  • Retina Center Northwest
  • Spokane Eye Clinical Research
  • West Virginia University Eye Institute
  • University of Wisconsin
  • Organizacion Medica de Investigacion
  • Fundacion Zambrano
  • Oftar
  • Microcirugía Ocular S.A
  • Grupo Laser Vision
  • Eyeclinic Albury Wodonga
  • Marsden Eye Research Centre
  • Save Sight Institute
  • Sydney West Retina
  • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
  • CHU Brugmann (Victor Horta)
  • UZ Gent
  • UZ Leuven Sint Rafael
  • CHU Sart-Tilman
  • Calgary Retina Consultants
  • University of British Columbia
  • QEII - HSC Department of Ophthalmology
  • University of Ottawa Eye Institute
  • Sunnybrook Health Sciences Centre
  • St. Michael'S Hospital
  • University Health Network Toronto Western Hospital
  • Institut De L'Oeil Des Laurentides
  • Sjællands Universitetshospital, Roskilde; Øjenafdelingen
  • Chi De Creteil; Ophtalmologie
  • Centre Odeon; Exploration Ophtalmologique
  • Hopital Lariboisiere; Ophtalmologie
  • Centre Ophtalmologique; Imagerie et laser
  • Ch Pitie Salpetriere; Ophtalmologie
  • CHU Poitiers - CHR La Miletrie; Ophtalmologie
  • Universitäts-Augenklinik Bonn
  • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
  • Medizinische Hochschule Hannover, Klinik für Augenheilkunde
  • Universitätsklinikum Köln; Augenklinik
  • Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
  • Augenabteilung am St. Franziskus-Hospital
  • Universitätsklinikum Münster; Augenheilkunde
  • Budapest Retina Associates Kft.
  • Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
  • Ganglion Medial Center
  • Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
  • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
  • Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica
  • Macula Retina Consultores
  • Hospital de la Ceguera APEC
  • Academisch Medisch Centrum Universiteit Amsterdam
  • Leids Universitair Medisch Centrum
  • Radboud University Nijmegen Medical Centre; Ophthalmology
  • CLINICA RICARDO PALMA; Oftalmologos Contreras
  • Clinica Anglo Americana
  • OFTALMIKA Sp. z o.o
  • Optimum Profesorskie Centrum Okulistyki
  • Gabinet Okulistyczny Prof Edward Wylegala
  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
  • Nemocnica sv. Michala, a.s.
  • Fakultna nemocnica Trencin Ocna klinika
  • Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
  • Hospital Universitari de Bellvitge; Servicio de Oftalmologia
  • Hospital General de Catalunya
  • Instituto Clinico Quirurgico de Oftalmologia - ICQO
  • VISSUM Instituto Oftalmológico de Alicante
  • Institut de la Macula i la retina
  • FISABIO. Fundación Oftalmologica del Mediterraneo
  • Hospital Universitario Rio Hortega; Servicio de Oftalmologia
  • Stadtspital Triemli; Augenklinik
  • Ayr Hospital
  • The Princess Alexandra Eye Pavilion
  • Frimley Park Hospital
  • Royal Hallamshire Hospita

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 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.

Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.

Participants will receive sham comparator Q4W or Q6W for 96 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Geographic Atrophy (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 as Assessed by Mesopic Micrometry 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, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.
Change From Baseline in Mean 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. The data was 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). BCVA score testing was performed prior to dilating the eyes. 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. The data was 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 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). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was 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 LLVA 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. LLVA 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). The data was 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. The data was 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. The data was 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 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 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, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; 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 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
June 17, 2019
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02247479
Brief Title
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Acronym
CHROMA
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
June 2019
Overall Recruitment Status
Terminated
Study Start Date
September 18, 2014 (Actual)
Primary Completion Date
January 29, 2018 (Actual)
Study Completion Date
January 29, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

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
906 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lampalizumab Once in Every 4 Weeks (Q4W)
Arm Type
Experimental
Arm Description
Participants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
Arm Title
Lampalizumab Once in Every 6 Weeks (Q6W)
Arm Type
Experimental
Arm Description
Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
Arm Title
Sham Comparator
Arm Type
Sham Comparator
Arm Description
Participants will receive sham comparator Q4W or Q6W for 96 weeks.
Intervention Type
Drug
Intervention Name(s)
Lampalizumab
Other Intervention Name(s)
RO5490249
Intervention Description
Participants will receive 10 mg dose of lampalizumab administered intravitreally.
Intervention Type
Other
Intervention Name(s)
Sham
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 Atrophy (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 as Assessed by Mesopic Micrometry 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, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.
Time Frame
Baseline, Week 48
Title
Change From Baseline in Mean 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. 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 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). BCVA score testing was performed prior to dilating the eyes. 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. 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
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). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was 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 LLVA 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. LLVA 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). 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
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. The data was 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. 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 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 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 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, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; 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 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: 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 (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
Uni of Alabama At Birmingham Clinical Research Unit
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Retinal Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retina Centers P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
The Gavin Herbert Eye Institute - UC, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697-4375
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
East Bay Retina Consultants
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Southern CA Desert Retina Cons
City
Palm Desert
State/Province
California
ZIP/Postal Code
92211
Country
United States
Facility Name
W Coast Retina Med Group Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
UCSF; Ophthalmology
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Orange County Retina Med Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Florida Eye Microsurgical Inst
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Retina Care Specialists
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33418
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Fort Lauderdale Eye Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
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
Retina Associates of Florida, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Georgia Retina PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Retina Consultants of Hawaii
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Northwestern Medical Group/Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University Retina and Macula Associates, PC
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Facility Name
Midwest Eye Institute Northside
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Retina Associates
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Lahey Clinic Med Ctr
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
02421
Country
United States
Facility Name
Retina Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Maine Eye Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
Retina Specialists
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Tufts Medical Center Research
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Vitreo-Retinal Associates, PC
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Vitreo-Retinal Associates
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Specialty Eye Institute
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49202
Country
United States
Facility Name
Assoc Retinal Consultants PC
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Retina Consultants of Michigan
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Eye Surgical Associates
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Retina Consultants of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Retina Center of New Jersey
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
New Jersey Retina Research Foundation
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
Delaware Valley Retina Assoc
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Long Is. Vitreoretinal Consult
City
Hauppauge
State/Province
New York
ZIP/Postal Code
11788
Country
United States
Facility Name
Opthalmic Consultants of LI
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
New York Eye & Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Retina Consultants of Western New York
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
Retina Vit Surgeons/Central NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
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
Wake Forest Baptist Health Eye Centre
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Retina Assoc of Cleveland Inc
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Cleveland Clinic Foundation; Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Retina Vitreous Consultants
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
Associates in Ophthalmology
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
Charleston Neuroscience Inst
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Tennessee Retina PC.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
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
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
UT Southwestern MC at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Valley Retina Institute P.A.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Strategic Clinical Research Group, LLC
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
Retina Associates of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Eye Surgeons of Richmond Inc. dba Virginia Eye Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Retina Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Virginia Retina Center
City
Warrenton
State/Province
Virginia
ZIP/Postal Code
20186
Country
United States
Facility Name
Retina Center Northwest
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
West Virginia University Eye Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Organizacion Medica de Investigacion
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Fundacion Zambrano
City
Caba
ZIP/Postal Code
1023
Country
Argentina
Facility Name
Oftar
City
Mendoza
ZIP/Postal Code
M5500GGK
Country
Argentina
Facility Name
Microcirugía Ocular S.A
City
Rosario
ZIP/Postal Code
S2000CTC
Country
Argentina
Facility Name
Grupo Laser Vision
City
Rosario
ZIP/Postal Code
S2000DLA
Country
Argentina
Facility Name
Eyeclinic Albury Wodonga
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Marsden Eye Research Centre
City
Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Save Sight Institute
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Sydney West Retina
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
CHU Brugmann (Victor Horta)
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven Sint Rafael
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Calgary Retina Consultants
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 0C8
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada
Facility Name
QEII - HSC Department of Ophthalmology
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
University of Ottawa Eye Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael'S Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
University Health Network Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Institut De L'Oeil Des Laurentides
City
Boisbriand
State/Province
Quebec
ZIP/Postal Code
J7H 1S6
Country
Canada
Facility Name
Sjællands Universitetshospital, Roskilde; Øjenafdelingen
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Chi De Creteil; Ophtalmologie
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Odeon; Exploration Ophtalmologique
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
Hopital Lariboisiere; Ophtalmologie
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Ophtalmologique; Imagerie et laser
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Ch Pitie Salpetriere; Ophtalmologie
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU Poitiers - CHR La Miletrie; Ophtalmologie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Universitäts-Augenklinik Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Köln; Augenklinik
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Augenabteilung am St. Franziskus-Hospital
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Universitätsklinikum Münster; Augenheilkunde
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Budapest Retina Associates Kft.
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
City
Debrecem
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Ganglion Medial Center
City
Pecs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
City
Roma
State/Province
Lazio
ZIP/Postal Code
00198
Country
Italy
Facility Name
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07100
Country
Italy
Facility Name
Macula Retina Consultores
City
Mexico, D.F.
ZIP/Postal Code
01120
Country
Mexico
Facility Name
Hospital de la Ceguera APEC
City
Mexico, D.F.
ZIP/Postal Code
04030
Country
Mexico
Facility Name
Academisch Medisch Centrum Universiteit Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA0
Country
Netherlands
Facility Name
Radboud University Nijmegen Medical Centre; Ophthalmology
City
Nijmegen
ZIP/Postal Code
6525 EX
Country
Netherlands
Facility Name
CLINICA RICARDO PALMA; Oftalmologos Contreras
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Clinica Anglo Americana
City
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
OFTALMIKA Sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Facility Name
Optimum Profesorskie Centrum Okulistyki
City
Gdańsk
ZIP/Postal Code
80-809
Country
Poland
Facility Name
Gabinet Okulistyczny Prof Edward Wylegala
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Nemocnica sv. Michala, a.s.
City
Bratislava
ZIP/Postal Code
81108
Country
Slovakia
Facility Name
Fakultna nemocnica Trencin Ocna klinika
City
Trencin
ZIP/Postal Code
911 71
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Hospital Universitari de Bellvitge; Servicio de Oftalmologia
City
Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Hospital General de Catalunya
City
San Cugat Del Valles
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Instituto Clinico Quirurgico de Oftalmologia - ICQO
City
Bilbao
State/Province
Guipuzcoa
ZIP/Postal Code
48006
Country
Spain
Facility Name
VISSUM Instituto Oftalmológico de Alicante
City
Alicante
ZIP/Postal Code
03016
Country
Spain
Facility Name
Institut de la Macula i la retina
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
FISABIO. Fundación Oftalmologica del Mediterraneo
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Stadtspital Triemli; Augenklinik
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Ayr Hospital
City
AYR
ZIP/Postal Code
KA6 6DX
Country
United Kingdom
Facility Name
The Princess Alexandra Eye Pavilion
City
Edinburgh
ZIP/Postal Code
EH3 9HA
Country
United Kingdom
Facility Name
Frimley Park Hospital
City
Frimley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Royal Hallamshire Hospita
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33383315
Citation
Miere A, Capuano V, Kessler A, Zambrowski O, Jung C, Colantuono D, Pallone C, Semoun O, Petit E, Souied E. Deep learning-based classification of retinal atrophy using fundus autofluorescence imaging. Comput Biol Med. 2021 Mar;130:104198. doi: 10.1016/j.compbiomed.2020.104198. Epub 2020 Dec 28.
Results Reference
derived
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 Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

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