Back to resultsAn Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD (GALE)
Primary Purpose
Geographic Atrophy Secondary to Age-related Macular Degeneration
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PEGCETACOPLAN (APL-2)
Sponsored by
About this trial
This is an interventional treatment trial for Geographic Atrophy Secondary to Age-related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Ocular-specific inclusion criteria apply to the study eye only.
- Subjects must have participated in APL2-103 (NCT03777332) or completed the treatment at Month 24 of either APL2-303 (Derby, NCT03525613) or APL2-304 (Oaks, NCT03525600).
For subjects who participated in either the 303 or 304 studies, the condition listed below must also be met for participating in this study.
- Subjects who did not fully stop study drug treatment, but missed the visit at Month 24, can also participate in the study. However, to participate, subjects must be seen within 60 days from the last day of the period allowed for the 24 months visit in the previous study.
- The eyes of subjects must have transparency to permit visualization of parts inside the eye such as the retina and subjects must be able to look steadily at a provided target allowing the doctor to get good quality pictures from the eye.
Female subjects must be:
- Women that cannot have children, or
- Women who can have children must have a negative result of a blood pregnancy test on the first day of the study visit and agree to use ways to avoid pregnancy during the study and 90 days after the last dose of the study medication.
- Males with female partners who can get pregnant must also agree to use ways to avoid pregnancy and agree not to donate sperm while in the study or until 90 days after administering the last dose of the study medication.
- Agree to participate in the study by signing the consent document providing information about the study; and take part in all tests and assessments as required.
Exclusion Criteria:
Subjects cannot take part in the study if the eye that will be treated during the study currently meets any of the following conditions:
- Participants in APL2 303/304 studies who fully stopped study drug treatment before the visit in month 24 but remain in the study to observe the study medication's safety. Those subjects who temporarily paused study drug treatment are still eligible to participate.
- If, according to your doctor you currently have any disease affecting your eyes that could interfere with your vision, including diseases that affect your retina or macula (the center of the back of your eyes). And, if according to your doctor, the disease in your eyes is benign and does not interfere with the study (e.g. diseases that affects the periphery of the retina), you are also eligible to take part in the study.
- If, according to your doctor you currently have any inflammation/infection in or around your eyes that could prohibit you from receiving an injection inside your eyes.
- If, according to your doctor, any current disease that could directly interfere in your participation in the study or that could make it difficult for you to come to the scheduled visits during the next three yearsover the next 36 months.
- If you have known allergies to fluorescein sodium, a solution that is injected into your body for eye testing; or to pegcetacoplan (the study drug) or any inactive substances in pegcetacoplan solution.
- If you currently are pregnant, breastfeed or have a positive pregnancy test.
Sites / Locations
- Retinal Research Institue, LLC
- Associated Retina Consultants, Ltd.
- California Retina Consultants
- Retinal Diagnostic Center
- The Retina Partners
- Retina Consultants of Orange County
- Atlantis Eyecare
- Jacobs Retina Center, UCSD
- Doheny Eye Center UCLA
- Northern California Retina Vitreous Associates
- Retina Institute of California Medical Group
- Byers Eye Institute, Stanford University
- Retina Consultants San Diego
- Orange County Retina Medical Group
- California Retina Consultants
- Bay Area Retina Associates
- Southwest Retina Research Center, LLC
- Danbury Eye Physicians & Surgeons, PC
- Retina Group of New England - New London
- Florida Eye Microsurgical Institute, Inc.
- Blue Ocean Clinical Research
- Pinnacle Research Insitute
- Retina Health Center
- National Opthalmic Research Institute
- Bascom Palmer Eye Institute
- Bascom Palmer Eye Institute at Naples
- Palm Beach Gardens
- Retina Specialty Institute
- Eye Associates of Pinellas
- East Florida Eye Institute
- Retina Associates of Florida
- University of South Florida
- Center for Retina and Macular Disease
- Southeast Retina Center, PC
- Georgia Retina, PC
- Gailey Eye Clinic Retina Center
- Northwestern Feinberg School of Medicine
- Rush University Medical Center
- Midwest Eye Institute
- Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky
- The Retina Care Center
- Elman Retina Group
- The Retina Group of Washington
- Cumberland Valley Retina Center
- Mid Atlantic Retina Specialist
- Ophthalmic Consultants of Boston
- Tufts Medical Center
- New England Retina Consultants, PC
- Michigan Medicine Kellogg Eye Center
- Associated Retinal Consultants, PC
- Associated Retinal Consultants, PC
- Vitreoretinal Surgery
- Sierra Eye Associates
- Sara Gater
- Retina Center of NJ, LLC
- NJ Retina
- NJ Retina
- Vision Research Center Eye Associates of NM
- Long Island Vitreoretinal Consultants
- Vitreous Retina Macula Consultants of New York
- Ophthalmic Consultants of Long Island
- Western Carolina Retinal Associates
- Charlotte Eye Ear Nose and Throat Associates, PS
- Duke University, Duke Eye Center
- Graystone Eye
- Retina Associates of Cleveland, Inc.
- Retina Associates of Cleveland
- Cleveland Clinic Cole Eye Institute
- The Ohio State University
- Retina Associates of Cleveland, Inc.
- Retina Vitreous Center, PLLC
- Oregon Retina LLP
- Retina Northwest, PC
- Eye Health Northwest
- Mid Atlantic Retina
- Retina Vitreous Consultants
- Mid Atlantic Retina
- Mid Atlantic Retina
- AIO Visionary Eye Care
- Black Hills Regional Eye Institute
- Charles Retina Institute
- Tennessee Retina, PC
- Retina Research Center PLLC
- Brown Retina Institute
- Texas Retina Associates
- Houston Eye Associates
- Retina Consultants of Houston, PA
- Valley Retina Institute
- Medical Center Ophthalmology Associates
- Retina Associates of South Texas
- Retina Consultants of Houston
- Retina Associates of Utah, PC
- University of Utah - John A. Moran Center
- University of Virginia
- The Retina Group of Washington
- Emerson Clinical Research Institute
- Vitreoretinal Associates of Washington
- Spokane Eye Clinical Research
- Retina Health Center
- Retina-Vitreous Associates Medical Group
- Diagnostico Ocular
- Organizacion Medica de Investigacion (OMI)
- Fundacion Zambrano
- Centro Oftalmologico Dr. Charles S.A.
- Instituto Oftalmologico de Cordoba
- OFTAR
- Microcirujia Ocular Rosario
- Oftalmologos Especialistas
- Marsden Eye Specialist
- Strathfield Retina Clinic
- Sydney Retina
- The Ashley Centre
- Centre for Eye Research Australia
- Retina and Eye Consultantss
- Lions Eye Institute
- Save Sight Institute
- IPEPO Instituto Da Visao
- Ivey Eye Institute
- University of Ottawa Eye Institute
- Retina Centre of Ottawa
- Fakultni Nemocnice Ostrava
- University hospital Kralovske Vinohrady
- AXON Clinical, s.r.o.
- Vseobecna fakultni nemocnice v Praze
- Gemini Eye Clinic
- Centre ophtalmologique Saint-Exupery
- CHU de Bordeaux
- Centre Hospitalier Intercommunal de Creteil
- CHU Dijon
- Hopital de la Croix-Rousse
- Centre monticelli Paradis
- CHU de Nantes - Hotel Dieu
- Centre Ophtalmol de l Odeon
- Hopital Lariboisiere
- CHNO des Quinze-Vingts
- Centre Ophtalmo. Image/Laser
- Maison Rouge Ophthalmologic Center
- CHU de Strasbourg Hopital Civil
- Clinique du Val d'Ouest
- Universitats-Augenklinik Bonn
- Uniklinik Koln
- University Opthalmology Clinic
- Uni-medizin Gottingen Augenklinik 3.B1.261
- Klinikum der Stadt Ludwigshafen gGmbH
- Universitatsklinikum Schleswig-Holstein
- Augenklinik der LMU Munchen
- Klinikum rechts der Isar
- Augenzentrum am St. Franziskus-Hospital
- Universitatsklinikum Regensburg
- Universitatsklinikum Munster
- STZ Eyetrial
- Assaf ha Rofeh MC
- Rambam Health Care Campus
- Hadassah Medical Center
- Tel Aviv Sourasky Medical Center
- IRCCS San Raffaele
- ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco
- Academisch Medisch Centrum
- Radboud university medical center Oogheelkunde
- Southern Eye Specialists
- Hamilton Eye Clinic
- Eye Surgery Center Professor Zagorski
- Oftalmika Eye Hospital
- Grupo Laser Vision
- Oculomedica Eye Centre
- UNO-MED Centrum Medyne
- Hospital Universitario Puerta de Hierro
- Instituto Oftalmologico Gomez-Ulla
- Huddersfield Royal Infirmary
- St James's University Hospital
- Bristol Eye Hospital
- Royal Liverpool University Hospital
- Kings College Hospital NHS Trust
- London Vision Clinic
- Oxford Eye Hospital
- Sunderland Eye Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pegcetacoplan, 15 mg/100 μL, monthly for up to 36 months
Pegcetacoplan, 15 mg/100 μL, every other month (EOM) for up to 36 months
Arm Description
Participants from Study APL2-103 (NCT03777332) or those who completed the treatment at Month 24 from either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600) and were administered monthly intravitreal (IVT) pegcetacoplan (15 mg/100 μL) or monthly sham will receive IVT pegcetacoplan (15 mg/100 μL) monthly for up to approximately 36 months.
Participants from Study APL2-103 (NCT03777332) or those who completed the treatment at Month 24 from either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600) and were administered every other month (EOM) intravitreal (IVT) pegcetacoplan (15 mg/100 μL) or EOM sham will receive IVT pegcetacoplan (15 mg/100 μL) EOM for up to approximately 36 months.
Outcomes
Primary Outcome Measures
Incidence and severity of ocular and systemic adverse events
Secondary Outcome Measures
Change from baseline in the total area of GA lesion(s) in the study eye (in mm2)
The total area of GA lesion(s) in the study eye (in mm2) as assessed by FAF at Month 12, Month 24, and Month 36
Change from baseline in NL-BCVA score (study eye)
NL-BCVA score as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Month 12, Month 24, and Month 36
Change from baseline in LL-BCVA score (study eye)
LL-BCVA score as assessed by ETDRS chart at Month 12, Month 24, and Month 36
Full Information
NCT ID
NCT04770545
First Posted
February 23, 2021
Last Updated
August 30, 2023
Sponsor
Apellis Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04770545
Brief Title
An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD
Acronym
GALE
Official Title
A Phase 3, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apellis Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase 3, open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan (APL-2) in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who participated in Study APL2-103 (NCT03777332) or completed the treatment at Month 24 of either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy Secondary to Age-related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pegcetacoplan, 15 mg/100 μL, monthly for up to 36 months
Arm Type
Experimental
Arm Description
Participants from Study APL2-103 (NCT03777332) or those who completed the treatment at Month 24 from either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600) and were administered monthly intravitreal (IVT) pegcetacoplan (15 mg/100 μL) or monthly sham will receive IVT pegcetacoplan (15 mg/100 μL) monthly for up to approximately 36 months.
Arm Title
Pegcetacoplan, 15 mg/100 μL, every other month (EOM) for up to 36 months
Arm Type
Experimental
Arm Description
Participants from Study APL2-103 (NCT03777332) or those who completed the treatment at Month 24 from either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600) and were administered every other month (EOM) intravitreal (IVT) pegcetacoplan (15 mg/100 μL) or EOM sham will receive IVT pegcetacoplan (15 mg/100 μL) EOM for up to approximately 36 months.
Intervention Type
Drug
Intervention Name(s)
PEGCETACOPLAN (APL-2)
Intervention Description
Complement (C3) Inhibitor
Primary Outcome Measure Information:
Title
Incidence and severity of ocular and systemic adverse events
Time Frame
Up to 36 Months
Secondary Outcome Measure Information:
Title
Change from baseline in the total area of GA lesion(s) in the study eye (in mm2)
Description
The total area of GA lesion(s) in the study eye (in mm2) as assessed by FAF at Month 12, Month 24, and Month 36
Time Frame
Up to 36 Months
Title
Change from baseline in NL-BCVA score (study eye)
Description
NL-BCVA score as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Month 12, Month 24, and Month 36
Time Frame
Up to 36 Months
Title
Change from baseline in LL-BCVA score (study eye)
Description
LL-BCVA score as assessed by ETDRS chart at Month 12, Month 24, and Month 36
Time Frame
Up to 36 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Ocular-specific inclusion criteria apply to the study eye only.
Subjects must have participated in APL2-103 (NCT03777332) or completed the treatment at Month 24 of either APL2-303 (Derby, NCT03525613) or APL2-304 (Oaks, NCT03525600).
For subjects who participated in either the 303 or 304 studies, the condition listed below must also be met for participating in this study.
Subjects who did not fully stop study drug treatment, but missed the visit at Month 24, can also participate in the study. However, to participate, subjects must be seen within 60 days from the last day of the period allowed for the 24 months visit in the previous study.
The eyes of subjects must have transparency to permit visualization of parts inside the eye such as the retina and subjects must be able to look steadily at a provided target allowing the doctor to get good quality pictures from the eye.
Female subjects must be:
Women that cannot have children, or
Women who can have children must have a negative result of a blood pregnancy test on the first day of the study visit and agree to use ways to avoid pregnancy during the study and 90 days after the last dose of the study medication.
Males with female partners who can get pregnant must also agree to use ways to avoid pregnancy and agree not to donate sperm while in the study or until 90 days after administering the last dose of the study medication.
Agree to participate in the study by signing the consent document providing information about the study; and take part in all tests and assessments as required.
Exclusion Criteria:
Subjects cannot take part in the study if the eye that will be treated during the study currently meets any of the following conditions:
Participants in APL2 303/304 studies who fully stopped study drug treatment before the visit in month 24 but remain in the study to observe the study medication's safety. Those subjects who temporarily paused study drug treatment are still eligible to participate.
If, according to your doctor you currently have any disease affecting your eyes that could interfere with your vision, including diseases that affect your retina or macula (the center of the back of your eyes). And, if according to your doctor, the disease in your eyes is benign and does not interfere with the study (e.g. diseases that affects the periphery of the retina), you are also eligible to take part in the study.
If, according to your doctor you currently have any inflammation/infection in or around your eyes that could prohibit you from receiving an injection inside your eyes.
If, according to your doctor, any current disease that could directly interfere in your participation in the study or that could make it difficult for you to come to the scheduled visits during the next three yearsover the next 36 months.
If you have known allergies to fluorescein sodium, a solution that is injected into your body for eye testing; or to pegcetacoplan (the study drug) or any inactive substances in pegcetacoplan solution.
If you currently are pregnant, breastfeed or have a positive pregnancy test.
Facility Information:
Facility Name
Retinal Research Institue, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Associated Retina Consultants, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Retinal Diagnostic Center
City
Campbell
State/Province
California
ZIP/Postal Code
95508
Country
United States
Facility Name
The Retina Partners
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Atlantis Eyecare
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Jacobs Retina Center, UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Doheny Eye Center UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retina Institute of California Medical Group
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Byers Eye Institute, Stanford University
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
Orange County Retina Medical 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
Southwest Retina Research Center, LLC
City
Durango
State/Province
Colorado
ZIP/Postal Code
81301
Country
United States
Facility Name
Danbury Eye Physicians & Surgeons, PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Retina Group of New England - New London
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06835
Country
United States
Facility Name
Florida Eye Microsurgical Institute, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Blue Ocean Clinical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Pinnacle Research Insitute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Retina Health Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
National Opthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Bascom Palmer Eye Institute at Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34103
Country
United States
Facility Name
Palm Beach Gardens
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
Eye Associates of Pinellas
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
East Florida Eye Institute
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
Retina Associates of Florida
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
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Southeast Retina Center, PC
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
Gailey Eye Clinic Retina Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Northwestern Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
The Retina Care Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Elman Retina Group
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
The Retina Group of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
92705
Country
United States
Facility Name
Cumberland Valley Retina Center
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Mid Atlantic Retina Specialist
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
Facility Name
New England Retina Consultants, PC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Michigan Medicine Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Associated Retinal Consultants, PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Associated Retinal Consultants, PC
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49686
Country
United States
Facility Name
Vitreoretinal Surgery
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
Sara Gater
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03244
Country
United States
Facility Name
Retina Center of NJ, LLC
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
NJ Retina
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
NJ Retina
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Vision Research Center Eye Associates of NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Long Island Vitreoretinal Consultants
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Vitreous Retina Macula Consultants of New York
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Oceanside
State/Province
New York
ZIP/Postal Code
11572
Country
United States
Facility Name
Western Carolina Retinal Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Associates, PS
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Duke University, Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Graystone Eye
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Retina Associates of Cleveland, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Retina Associates of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Cleveland Clinic Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Retina Associates of Cleveland, Inc.
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44505
Country
United States
Facility Name
Retina Vitreous Center, PLLC
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Oregon Retina LLP
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97405
Country
United States
Facility Name
Retina Northwest, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97221
Country
United States
Facility Name
Eye Health Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Mid Atlantic Retina
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18107
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
19006
Country
United States
Facility Name
Mid Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
AIO Visionary Eye Care
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Charles Retina Institute
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
78503
Country
United States
Facility Name
Retina Research Center PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Brown Retina Institute
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Retina Consultants of Houston, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Associates of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Retina Associates of Utah, PC
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah - John A. Moran Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84312
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
The Retina Group of Washington
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Emerson Clinical Research Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22046
Country
United States
Facility Name
Vitreoretinal Associates of Washington
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Retina Health Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Diagnostico Ocular
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Organizacion Medica de Investigacion (OMI)
City
Buenos Aires
ZIP/Postal Code
C1015 ABO
Country
Argentina
Facility Name
Fundacion Zambrano
City
Buenos Aires
ZIP/Postal Code
C1023 AAQ
Country
Argentina
Facility Name
Centro Oftalmologico Dr. Charles S.A.
City
Buenos Aires
ZIP/Postal Code
C1116ABA
Country
Argentina
Facility Name
Instituto Oftalmologico de Cordoba
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
OFTAR
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Microcirujia Ocular Rosario
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Oftalmologos Especialistas
City
Santa Fe
ZIP/Postal Code
S2000
Country
Argentina
Facility Name
Marsden Eye Specialist
City
Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Strathfield Retina Clinic
City
Strathfield
State/Province
New South Wales
ZIP/Postal Code
2135
Country
Australia
Facility Name
Sydney Retina
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
The Ashley Centre
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Centre for Eye Research Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Retina and Eye Consultantss
City
Hurstville
ZIP/Postal Code
2220
Country
Australia
Facility Name
Lions Eye Institute
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Save Sight Institute
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
IPEPO Instituto Da Visao
City
São Paulo
ZIP/Postal Code
04038-032
Country
Brazil
Facility Name
Ivey Eye Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
University of Ottawa Eye Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Retina Centre of Ottawa
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2B 7E9
Country
Canada
Facility Name
Fakultni Nemocnice Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
University hospital Kralovske Vinohrady
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Facility Name
AXON Clinical, s.r.o.
City
Prague
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha
ZIP/Postal Code
2128 08
Country
Czechia
Facility Name
Gemini Eye Clinic
City
Zlín
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Centre ophtalmologique Saint-Exupery
City
Saint-Cyr-sur-Loire
State/Province
Lyon
ZIP/Postal Code
37540
Country
France
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier Intercommunal de Creteil
City
Créteil cedex
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21 079
Country
France
Facility Name
Hopital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Centre monticelli Paradis
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
CHU de Nantes - Hotel Dieu
City
Nantes Cedex
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Ophtalmol de l Odeon
City
Paris
ZIP/Postal Code
75006
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHNO des Quinze-Vingts
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Centre Ophtalmo. Image/Laser
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Maison Rouge Ophthalmologic Center
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
CHU de Strasbourg Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Clinique du Val d'Ouest
City
Écully
ZIP/Postal Code
69130
Country
France
Facility Name
Universitats-Augenklinik Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Uniklinik Koln
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
University Opthalmology Clinic
City
Freiburg im Breisgau
ZIP/Postal Code
79106
Country
Germany
Facility Name
Uni-medizin Gottingen Augenklinik 3.B1.261
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen gGmbH
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Augenklinik der LMU Munchen
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Klinikum rechts der Isar
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Augenzentrum am St. Franziskus-Hospital
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Universitatsklinikum Regensburg
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Universitatsklinikum Munster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
STZ Eyetrial
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Assaf ha Rofeh MC
City
Be'er Ya'akov
ZIP/Postal Code
7030000
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
IRCCS San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Radboud university medical center Oogheelkunde
City
Nijmegen
ZIP/Postal Code
6525 EX
Country
Netherlands
Facility Name
Southern Eye Specialists
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Hamilton Eye Clinic
City
Hamilton
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Eye Surgery Center Professor Zagorski
City
Bydgoszcz
ZIP/Postal Code
85-316
Country
Poland
Facility Name
Oftalmika Eye Hospital
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Facility Name
Grupo Laser Vision
City
Rzeszów
ZIP/Postal Code
35-017
Country
Poland
Facility Name
Oculomedica Eye Centre
City
Tarnów
ZIP/Postal Code
33-100
Country
Poland
Facility Name
UNO-MED Centrum Medyne
City
Tarnów
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Instituto Oftalmologico Gomez-Ulla
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield
State/Province
West Yorkshire
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Bristol Eye Hospital
City
Bristol
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Kings College Hospital NHS Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
London Vision Clinic
City
London
ZIP/Postal Code
W1G 7LA
Country
United Kingdom
Facility Name
Oxford Eye Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Sunderland Eye Infirmary
City
Sunderland
ZIP/Postal Code
SR2 9HP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD
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