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Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)

Primary Purpose

Geographic Atrophy

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

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

Inclusion Criteria:

  • Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit
  • Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential

Exclusion Criteria:

  • Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
  • Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
  • Increased risk of infection
  • Pregnancy or lactation

Sites / Locations

  • Uni of Alabama At Birmingham Clinical Research Unit
  • Retinal Research Institute, LLC
  • Associated Retina Consultants
  • Retina Centers P.C.
  • Retina Associates Southwest PC
  • California Retina Consultants
  • Retina-Vitreous Associates Medical Group
  • Retina Consultants of Orange County
  • UCSD Shiley Eye Center
  • Jules Stein Eye Institute/ UCLA
  • N CA Retina Vitreous Assoc
  • East Bay Retina Consultants
  • Southern CA Desert Retina Cons
  • Byers Eye Insitute at Stanford
  • Retina Consultants, San Diego
  • University of California, Davis, Eye Center
  • Retinal Consultants Med Group
  • W Coast Retina Med Group Inc
  • UCSF Comprehensive Cancer Ctr; Ophthalmology
  • Orange County Retina Med Group
  • California Retina Consultants
  • Bay Area Retina Associates
  • University of Colorado
  • Retina Consultants of Southern
  • Colorado Retina Associates, PC
  • Retina Group of New England
  • Florida Eye Microsurgical Inst
  • Retina Group of Florida
  • Retina Health Center
  • National Ophthalmic Research Institute
  • Florida Eye Associates
  • Bascom Palmer Eye Institute
  • 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
  • University of South Florida
  • Southeast Retina Center
  • Georgia Retina PC
  • Retina Consultants of Hawaii
  • Midwest Eye Institute Northside
  • Wolfe Eye Clinic
  • Retina Associates
  • Vitreo Retinal Consultants
  • Lahey Clinic Med Ctr
  • Retina Associates of Kentucky
  • Paducah Retinal Center
  • Maine Eye Center
  • The Retina Care Center
  • Wilmer Eye Institute
  • Retina Group of Washington
  • Retina Specialists
  • Tufts Medical Center Research
  • Mass Eye and Ear Infirmary
  • Ophthalmic Consultants of Boston
  • Vitreo-Retinal Associates, PC
  • University of Michigan, Kellogg Eye Center
  • Kresge Eye Institute
  • Vitreo-Retinal Associates
  • Specialty Eye Institute
  • Assoc Retinal Consultants PC
  • Retina Consultants of Michigan
  • Vitreoretinal Surgery
  • Lifelong Vision Foundation
  • Retina Consultants of Nevada
  • Sierra Eye Associates
  • Retina Center of New Jersey
  • Mid Atlantic Retina - Wills Eye Hospital
  • New Jersey Retina Research Foundation
  • Delaware Valley Retina Assoc
  • Retinal & Ophthalmic Cons PC
  • Retina Associates of NJ
  • Lions Eye Institute
  • Long Is. Vitreoretinal Consult
  • Opthalmic Consultants of LI
  • New York Eye & Ear Infirmary
  • Vitreous-Retina-Macula
  • Retina Assoc of Western NY
  • Retina Vit Surgeons/Central NY
  • West Carolina Retinal AssocPA
  • Char Eye Ear &Throat Assoc
  • Duke University Eye Center; Vitreoretinal
  • Wake Forest Baptist Health Eye Centre
  • Cincinnati Eye Institute
  • Retina Assoc of Cleveland Inc
  • Cleveland Clinic Foundation; Cole Eye Institute
  • OSU Eye Physicians & Surgeons
  • Retina & Vitreous Center of Southern Oregon
  • Retina Northwest
  • Oregon HSU; Casey Eye Institute
  • Retina Vitreous Consultants
  • Mid Atlantic Retina
  • Associates in Ophthalmology
  • Palmetto Retina Center
  • Charleston Neuroscience Inst
  • Black Hills Eye Institute
  • Southeastern Retina Associates Chattanooga
  • Charles Retina Institution
  • Tennessee Retina PC.
  • Retina Res Institute of Texas
  • Texas Retina Associates
  • Austin Retina Associates
  • Retina Research Center
  • Texas Retina Associates
  • Retina Consultants of Houston
  • Valley Retina Institute P.A.
  • Scott and White Hospital
  • Retina Consultants of Houston
  • Strategic Clinical Research Group, LLC
  • Retina Associates of Utah
  • Univ of Virginia Ophthalmology
  • Eye Surgeons of Richmond Inc. dba Virginia Eye Institute
  • Retina Institute of Virginia
  • Virginia Retina Center
  • Vitreoretinal Associates of Washington
  • Retina Center Northwest
  • Spokane Eye Clinical Research
  • West Virginia University Eye Institute
  • University of Wisconsin
  • Eyeclinic Albury Wodonga
  • Marsden Eye Research Centre
  • Save Sight Institute
  • Sydney West Retina
  • Vision Eye Institute Eastern
  • Royal Victorian Eye and Ear Hospital
  • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
  • Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
  • CHU Brugmann (Victor Horta)
  • UZ Leuven Sint Rafael
  • Institut De L'Oeil Des Laurentides
  • Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37
  • Sjællands Universitetshospital, Roskilde; Øjenafdelingen
  • Hopital Pellegrin; Ophtalmologie
  • Chi De Creteil; Ophtalmologie
  • Hôpital de La Croix Rousse
  • Centre Monticelli Paradis d Ophtalmologie
  • CHU Nantes - Hôtel Dieu; Ophthalmology
  • Centre Odeon; Exploration Ophtalmologique
  • CHNO des Quinze Vingts; Ophtalmologie
  • Universitäts-Augenklinik Bonn
  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
  • Medizinische Hochschule Hannover, Klinik für Augenheilkunde
  • Universitätsklinik Heidelberg; Augenklinik
  • Universitätsklinikum Köln; Augenklinik
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
  • Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
  • LMU Klinikum der Universität, Augenklinik
  • Klinikum rechts der Isar der TU München; Augenklinik
  • Augenabteilung am St. Franziskus-Hospital
  • Universitätsklinikum Münster; Augenheilkunde
  • Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde
  • Universitätsklinikum Tübingen
  • Semmelweis Egyetem AOK, Szemeszeti Klinika
  • Budapest Retina Associates Kft.
  • Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
  • Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
  • Ganglion Medial Center
  • Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
  • 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
  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
  • Leids Universitair Medisch Centrum
  • TG Laser Oftalmica
  • OFTALMIKA Sp. z o.o
  • Szpital Specjalistyczny nr 1; Oddzial Okulistyki
  • Optimum Profesorskie Centrum Okulistyki
  • Gabinet Okulistyczny Prof Edward Wylegala
  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
  • 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
  • Nemocnica sv. Michala, a.s.
  • Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB
  • Fakultna nemocnica Trencin Ocna klinika
  • Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
  • Hospital Universitari de Bellvitge; Servicio de Oftalmologia
  • Instituto Clinico Quirurgico de Oftalmologia - ICQO
  • Instituto Oftalmologico Gomez Ulla
  • Clinica Universitaria de Navarra; Servicio de Oftalmologia
  • Hospital Perpetuo Socorro; Servicio de Oftalmología
  • Institut de la Macula i la retina
  • Instituto de microcirugia ocular
  • VISSUM Madrid Santa Hortensia
  • FISABIO. Fundación Oftalmologica del Mediterraneo
  • Hospital Universitario Rio Hortega; Servicio de Oftalmologia
  • Inselspital Bern, Universitätsklinik für Augenheilkunde
  • Vista Klinik Binningen
  • Stadtspital Triemli; Augenklinik
  • Hacettepe University Medical Faculty
  • Baskent University Ankara Hospital
  • 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
  • Macular Treatment Centre; Royal Eye 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 Type

Experimental

Experimental

Arm Label

Lampalizumab Every 4 Weeks

Lampalizumab Every 6 Weeks

Arm Description

Participants who received either lampalizumab or sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 milligrams (mg) via ITV injection, administered every 4 weeks.

Participants who received either lampalizumab or sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 mg via ITV injection, administered every 6 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Ocular Adverse Events (AEs) by Severity
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Percentage of Participants With Systemic (Non-Ocular) AEs by Severity
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.
Percentage of Participants With Anti-Lampalizumab Antibodies
The immunogenicity analysis included participants with at least one predose and one postdose anti-lampalizumab antibodies assessment. Predose was defined as prior to the first dose in the extension study for the prior sham participants, and prior to the first dose in the parent study for the prior lampalizumab participants.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2016
Last Updated
February 19, 2019
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02745119
Brief Title
Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
Official Title
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche-Sponsored Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Study Start Date
July 21, 2016 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 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 multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.

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
None (Open Label)
Allocation
Non-Randomized
Enrollment
994 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lampalizumab Every 4 Weeks
Arm Type
Experimental
Arm Description
Participants who received either lampalizumab or sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 milligrams (mg) via ITV injection, administered every 4 weeks.
Arm Title
Lampalizumab Every 6 Weeks
Arm Type
Experimental
Arm Description
Participants who received either lampalizumab or sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit will receive open-label lampalizumab as 10 mg via ITV injection, administered every 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Lampalizumab
Intervention Description
Lampalizumab 10 mg will be administered every 4 or 6 weeks according to the frequency given during participation in the parent study.
Primary Outcome Measure Information:
Title
Percentage of Participants With Ocular Adverse Events (AEs) by Severity
Description
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Time Frame
Up to approximately one year
Title
Percentage of Participants With Systemic (Non-Ocular) AEs by Severity
Description
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.
Time Frame
Up to approximately one year
Title
Percentage of Participants With Anti-Lampalizumab Antibodies
Description
The immunogenicity analysis included participants with at least one predose and one postdose anti-lampalizumab antibodies assessment. Predose was defined as prior to the first dose in the extension study for the prior sham participants, and prior to the first dose in the parent study for the prior lampalizumab participants.
Time Frame
Week 48

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential Exclusion Criteria: Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications Increased risk of infection Pregnancy or lactation
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
Associated Retina Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Retina Centers P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Retina Associates Southwest PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85750
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
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
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
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
W Coast Retina Med Group Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
UCSF Comprehensive Cancer Ctr; 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
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
80201
Country
United States
Facility Name
Retina Group of New England
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Florida Eye Microsurgical Inst
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
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
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
Bascom Palmer Eye Institute
City
Naples
State/Province
Florida
ZIP/Postal Code
34103
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
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
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
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
Vitreo Retinal Consultants
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
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
Paducah Retinal Center
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Maine Eye Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
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
Tufts Medical Center Research
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Mass Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
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
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
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
Vitreoretinal Surgery
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Lifelong Vision Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Retina Consultants of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
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
Mid Atlantic Retina - Wills Eye Hospital
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
New Jersey Retina Research Foundation
City
Edison
State/Province
New Jersey
ZIP/Postal Code
8820
Country
United States
Facility Name
Delaware Valley Retina Assoc
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
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
Lions Eye Institute
City
Albany
State/Province
New York
ZIP/Postal Code
12208
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
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
Retina Vit Surgeons/Central NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
Facility Name
West Carolina Retinal AssocPA
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
Wake Forest Baptist Health Eye Centre
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Retina Assoc of Cleveland Inc
City
Cleveland
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
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
Retina Vitreous Consultants
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
Mid Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Associates in Ophthalmology
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
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
Tennessee Retina PC.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
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
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
Valley Retina Institute P.A.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
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
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
Univ of Virginia Ophthalmology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
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
Vitreoretinal Associates of Washington
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
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
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
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
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
City
Linz
ZIP/Postal Code
4021
Country
Austria
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
Institut De L'Oeil Des Laurentides
City
Boisbriand
State/Province
Quebec
ZIP/Postal Code
J7H 1S6
Country
Canada
Facility Name
Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Sjællands Universitetshospital, Roskilde; Øjenafdelingen
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Hopital Pellegrin; Ophtalmologie
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Chi De Creteil; Ophtalmologie
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital de La Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Centre Monticelli Paradis d Ophtalmologie
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
CHU Nantes - Hôtel Dieu; Ophthalmology
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Odeon; Exploration Ophtalmologique
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
CHNO des Quinze Vingts; Ophtalmologie
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Universitäts-Augenklinik Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinik Heidelberg; Augenklinik
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Köln; Augenklinik
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
City
Lübeck
ZIP/Postal Code
23538
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
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
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
Semmelweis Egyetem AOK, Szemeszeti Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Budapest Retina Associates Kft.
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
City
Budapest
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
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
A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
City
Udine
State/Province
Veneto
ZIP/Postal Code
33100
Country
Italy
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
TG Laser Oftalmica
City
Lima
ZIP/Postal Code
27
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
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
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
Nemocnica sv. Michala, a.s.
City
Bratislava
ZIP/Postal Code
81108
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
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
Instituto Clinico Quirurgico de Oftalmologia - ICQO
City
Bilbao
State/Province
Guipuzcoa
ZIP/Postal Code
48006
Country
Spain
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
Institut de la Macula i la retina
City
Barcelona
ZIP/Postal Code
08022
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
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
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
Stadtspital Triemli; Augenklinik
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Baskent University Ankara Hospital
City
Ankara
ZIP/Postal Code
06490
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
Macular Treatment Centre; Royal Eye Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
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

Learn more about this trial

Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)

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