An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD
GALE
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
1 other identifier
interventional
792
15 countries
175
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2021
Typical duration for phase_3
175 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedStudy Start
First participant enrolled
March 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2025
CompletedOctober 24, 2025
June 1, 2025
4.5 years
February 23, 2021
October 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence and severity of ocular and systemic adverse events
Up to 36 Months
Secondary Outcomes (3)
Change from baseline in the total area of GA lesion(s) in the study eye (in mm2)
Up to 36 Months
Change from baseline in NL-BCVA score (study eye)
Up to 36 Months
Change from baseline in LL-BCVA score (study eye)
Up to 36 Months
Study Arms (2)
Pegcetacoplan, 15 mg/100 μL, monthly for up to 36 months
EXPERIMENTALParticipants 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.
Pegcetacoplan, 15 mg/100 μL, every other month (EOM) for up to 36 months
EXPERIMENTALParticipants 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.
Interventions
Complement (C3) Inhibitor
Eligibility Criteria
You may qualify if:
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (175)
Retinal Research Institue, LLC
Phoenix, Arizona, 85014, United States
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85020, United States
California Retina Consultants
Bakersfield, California, 93309, United States
Retinal Diagnostic Center
Campbell, California, 95508, United States
The Retina Partners
Encino, California, 91436, United States
Retina Consultants of Orange County
Fullerton, California, 92835, United States
Atlantis Eyecare
Huntington Beach, California, 92647, United States
Jacobs Retina Center, UCSD
La Jolla, California, 92093, United States
Doheny Eye Center UCLA
Los Angeles, California, 90033, United States
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
Retina Institute of California Medical Group
Palm Desert, California, 92260, United States
Byers Eye Institute, Stanford University
Palo Alto, California, 94303, United States
Retina Consultants San Diego
Poway, California, 92064, United States
Orange County Retina Medical Group
Santa Ana, California, 92705, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Southwest Retina Research Center, LLC
Durango, Colorado, 81301, United States
Danbury Eye Physicians & Surgeons, PC
Danbury, Connecticut, 06810, United States
Retina Group of New England - New London
Waterford, Connecticut, 06835, United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, 33426, United States
Blue Ocean Clinical Research
Clearwater, Florida, 33761, United States
Pinnacle Research Insitute
Fort Lauderdale, Florida, 33309, United States
Retina Health Center
Fort Myers, Florida, 33907, United States
National Opthalmic Research Institute
Fort Myers, Florida, 33912, United States
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
Bascom Palmer Eye Institute at Naples
Naples, Florida, 34103, United States
Palm Beach Gardens
Palm Beach Gardens, Florida, 33418, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Eye Associates of Pinellas
Pinellas Park, Florida, 33782, United States
East Florida Eye Institute
Stuart, Florida, 34994, United States
Retina Associates of Florida
Tampa, Florida, 33609, United States
University of South Florida
Tampa, Florida, 33612, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Southeast Retina Center, PC
Augusta, Georgia, 30909, United States
Georgia Retina, PC
Marietta, Georgia, 30060, United States
Gailey Eye Clinic Retina Center
Bloomington, Illinois, 61704, United States
Northwestern Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Midwest Eye Institute
Indianapolis, Indiana, 46290, United States
Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky
Lexington, Kentucky, 40509, United States
The Retina Care Center
Baltimore, Maryland, 21209, United States
Elman Retina Group
Baltimore, Maryland, 21236, United States
The Retina Group of Washington
Chevy Chase, Maryland, 92705, United States
Cumberland Valley Retina Center
Hagerstown, Maryland, 21740, United States
Mid Atlantic Retina Specialist
Hagerstown, Maryland, 21740, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Tufts Medical Center
Boston, Massachusetts, 02116, United States
New England Retina Consultants, PC
Springfield, Massachusetts, 01107, United States
Michigan Medicine Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
Associated Retinal Consultants, PC
Grand Rapids, Michigan, 49546, United States
Associated Retinal Consultants, PC
Traverse City, Michigan, 49686, United States
Vitreoretinal Surgery
Minneapolis, Minnesota, 55435, United States
Sierra Eye Associates
Reno, Nevada, 89503, United States
Retina Center of NJ, LLC
Bloomfield, New Jersey, 07003, United States
NJ Retina
Teaneck, New Jersey, 07666, United States
NJ Retina
Toms River, New Jersey, 08755, United States
Vision Research Center Eye Associates of NM
Albuquerque, New Mexico, 87109, United States
Long Island Vitreoretinal Consultants
Great Neck, New York, 11021, United States
Vitreous Retina Macula Consultants of New York
New York, New York, 10022, United States
Ophthalmic Consultants of Long Island
Oceanside, New York, 11572, United States
Western Carolina Retinal Associates
Asheville, North Carolina, 28803, United States
Charlotte Eye Ear Nose and Throat Associates, PS
Charlotte, North Carolina, 28210, United States
Duke University, Duke Eye Center
Durham, North Carolina, 27710, United States
Graystone Eye
Hickory, North Carolina, 28602, United States
Retina Associates of Cleveland, Inc.
Cleveland, Ohio, 44122, United States
Retina Associates of Cleveland
Cleveland, Ohio, 44130, United States
Cleveland Clinic Cole Eye Institute
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43212, United States
Retina Associates of Cleveland, Inc.
Youngstown, Ohio, 44505, United States
Retina Vitreous Center, PLLC
Edmond, Oklahoma, 73013, United States
Oregon Retina LLP
Eugene, Oregon, 97405, United States
Retina Northwest, PC
Portland, Oregon, 97221, United States
Eye Health Northwest
Portland, Oregon, 97225, United States
Mid Atlantic Retina
Bethlehem, Pennsylvania, 18107, United States
Retina Vitreous Consultants
Monroeville, Pennsylvania, 15146, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19006, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
AIO Visionary Eye Care
West Mifflin, Pennsylvania, 15122, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Charles Retina Institute
Germantown, Tennessee, 38138, United States
Tennessee Retina, PC
Nashville, Tennessee, 78503, United States
Retina Research Center PLLC
Austin, Texas, 78750, United States
Brown Retina Institute
Bellaire, Texas, 77401, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Houston Eye Associates
Houston, Texas, 77025, United States
Retina Consultants of Houston, PA
Houston, Texas, 77030, United States
Valley Retina Institute
McAllen, Texas, 78503, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Retina Associates of South Texas
San Antonio, Texas, 78240, United States
Retina Consultants of Houston
The Woodlands, Texas, 77384, United States
Retina Associates of Utah, PC
Murray, Utah, 84107, United States
University of Utah - John A. Moran Center
Salt Lake City, Utah, 84312, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
The Retina Group of Washington
Fairfax, Virginia, 22031, United States
Emerson Clinical Research Institute
Falls Church, Virginia, 22046, United States
Vitreoretinal Associates of Washington
Bellevue, Washington, 98004, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
Retina Health Center
Madison, Wisconsin, 53705, United States
Retina-Vitreous Associates Medical Group
Madison, Wisconsin, 53705, United States
Diagnostico Ocular
Buenos Aires, 1425, Argentina
Organizacion Medica de Investigacion (OMI)
Buenos Aires, C1015 ABO, Argentina
Fundacion Zambrano
Buenos Aires, C1023 AAQ, Argentina
Centro Oftalmologico Dr. Charles S.A.
Buenos Aires, C1116ABA, Argentina
Instituto Oftalmologico de Cordoba
Córdoba, 5000, Argentina
OFTAR
Mendoza, 5500, Argentina
Microcirujia Ocular Rosario
Rosario, 2000, Argentina
Oftalmologos Especialistas
Santa Fe, S2000, Argentina
Marsden Eye Specialist
Parramatta, New South Wales, 2150, Australia
Strathfield Retina Clinic
Strathfield, New South Wales, 2135, Australia
Sydney Retina
Sydney, New South Wales, 2000, Australia
The Ashley Centre
Westmead, New South Wales, 2145, Australia
Centre for Eye Research Australia
East Melbourne, Victoria, 3002, Australia
Retina and Eye Consultantss
Hurstville, 2220, Australia
Lions Eye Institute
Nedlands, 6009, Australia
Save Sight Institute
Westmead, 2145, Australia
IPEPO Instituto Da Visao
São Paulo, 04038-032, Brazil
Ivey Eye Institute
London, Ontario, N6A 4V2, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, K1H 8L6, Canada
Retina Centre of Ottawa
Ottawa, Ontario, K2B 7E9, Canada
Fakultni Nemocnice Ostrava
Ostrava-Poruba, 708 52, Czechia
University hospital Kralovske Vinohrady
Prague, 10034, Czechia
AXON Clinical, s.r.o.
Prague, 150 00, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 2128 08, Czechia
Gemini Eye Clinic
Zlín, 760 01, Czechia
Centre ophtalmologique Saint-Exupery
Saint-Cyr-sur-Loire, Lyon, 37540, France
CHU de Bordeaux
Bordeaux, 33076, France
Centre Hospitalier Intercommunal de Creteil
Créteil, 94010, France
CHU Dijon
Dijon, 21 079, France
Clinique du Val d'Ouest
Écully, 69130, France
Hopital de la Croix-Rousse
Lyon, 69004, France
Centre monticelli Paradis
Marseille, 13008, France
CHU de Nantes - Hotel Dieu
Nantes, 44093, France
Centre Ophtalmol de l Odeon
Paris, 75006, France
Hopital Lariboisiere
Paris, 75010, France
CHNO des Quinze-Vingts
Paris, 75012, France
Centre Ophtalmo. Image/Laser
Paris, 75015, France
Maison Rouge Ophthalmologic Center
Strasbourg, 67000, France
CHU de Strasbourg Hopital Civil
Strasbourg, 67091, France
Universitats-Augenklinik Bonn
Bonn, 53127, Germany
Uniklinik Koln
Cologne, 50937, Germany
University Opthalmology Clinic
Freiburg im Breisgau, 79106, Germany
Uni-medizin Gottingen Augenklinik 3.B1.261
Göttingen, 37075, Germany
Klinikum der Stadt Ludwigshafen gGmbH
Ludwigshafen, 67063, Germany
Universitatsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Augenklinik der LMU Munchen
München, 80336, Germany
Klinikum rechts der Isar
München, 81675, Germany
Augenzentrum am St. Franziskus-Hospital
Münster, 48145, Germany
Universitatsklinikum Regensburg
Münster, 48145, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
STZ Eyetrial
Tübingen, 72076, Germany
Assaf ha Rofeh MC
Be’er Ya‘aqov, 7030000, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Hadassah Medical Center
Jerusalem, 91120, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
IRCCS San Raffaele
Milan, 20132, Italy
ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco
Milan, 20157, Italy
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Radboud university medical center Oogheelkunde
Nijmegen, 6525 EX, Netherlands
Southern Eye Specialists
Christchurch, 8013, New Zealand
Hamilton Eye Clinic
Hamilton, 3204, New Zealand
Eye Surgery Center Professor Zagorski
Bydgoszcz, 85-316, Poland
Oftalmika Eye Hospital
Bydgoszcz, 85-631, Poland
Grupo Laser Vision
Rzeszów, 35-017, Poland
Oculomedica Eye Centre
Tarnów, 33-100, Poland
UNO-MED Centrum Medyne
Tarnów, 33-100, Poland
Hospital Universitario Puerta de Hierro
Madrid, 28222, Spain
Instituto Oftalmologico Gomez-Ulla
Santiago de Compostela, 15706, Spain
Kings College Hospital NHS Trust
London, London, SE5 9RS, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, West Yorkshire, HD3 3EA, United Kingdom
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Bristol Eye Hospital
Bristol, BS1 2LX, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
London Vision Clinic
London, W1G 7LA, United Kingdom
Oxford Eye Hospital
Oxford, OX3 9DU, United Kingdom
Sunderland Eye Infirmary
Sunderland, SR2 9HP, United Kingdom
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2021
First Posted
February 25, 2021
Study Start
March 4, 2021
Primary Completion
September 5, 2025
Study Completion
September 5, 2025
Last Updated
October 24, 2025
Record last verified: 2025-06