An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD

Completed · Phase 3

Conditions studied: Geographic Atrophy Secondary to Age-related Macular Degeneration

In brief

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).

Key facts

Study ID: NCT04770545
Run by: Apellis Pharmaceuticals, Inc.
People needed: 792
Starts: 2021-03-04
Expected to finish: 2025-09-05
Last updated by the study team: 2026-06-18

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

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.

Where it is running

Associated Retina Consultants, Ltd. — Phoenix, Arizona, United States
California Retina Consultants — Bakersfield, California, United States
Retinal Diagnostic Center — Campbell, California, United States
The Retina Partners — Encino, California, United States
Retina Consultants of Orange County — Fullerton, California, United States
Atlantis Eyecare — Huntington Beach, California, United States
Jacobs Retina Center, UCSD — La Jolla, California, United States
Doheny Eye Center UCLA — Los Angeles, California, United States
Northern California Retina Vitreous Associates — Mountain View, California, United States
Retina Institute of California Medical Group — Palm Desert, California, United States
Byers Eye Institute, Stanford University — Palo Alto, California, United States
Retina Consultants San Diego — Poway, California, United States
Orange County Retina Medical Group — Santa Ana, California, United States
California Retina Consultants — Santa Barbara, California, United States
Bay Area Retina Associates — Walnut Creek, California, United States
Southwest Retina Research Center, LLC — Durango, Colorado, United States
Danbury Eye Physicians & Surgeons, PC — Danbury, Connecticut, United States
Retina Group of New England - New London — Waterford, Connecticut, United States
Florida Eye Microsurgical Institute, Inc. — Boynton Beach, Florida, United States
Blue Ocean Clinical Research — Clearwater, Florida, United States
Pinnacle Research Insitute — Fort Lauderdale, Florida, United States
Retina Health Center — Fort Myers, Florida, United States
National Opthalmic Research Institute — Fort Myers, Florida, United States
Bascom Palmer Eye Institute — Miami, Florida, United States
Retinal Research Institue, LLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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