An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subj… (NCT04770545) | Clinical Trial Compass
CompletedPhase 3
An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD
United States, Argentina, Australia792 participantsStarted 2021-03-04
Plain-language 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).
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 administ…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was an extension study for pegcetacoplan given by eye injection for geographic atrophy — since it has now completed, has the full long-term safety data been published, and what does it show about serious eye-related side effects like infections or retinal problems?
2The primary thing this study was measuring was adverse events over the long term — does that mean there's still uncertainty about how much it actually slows vision loss, and how should that affect my decision about this treatment?
3Pegcetacoplan involves repeated injections into the eye — based on the data from this completed extension study, how often would I need those injections, and is that schedule realistic given my situation?
4Since this was a Phase 3 extension study, does the completed data support pegcetacoplan as a better option for my stage of geographic atrophy compared to simply monitoring or other available treatments?
5Are there any signals from this long-term study about risks that are specific to people with my overall health profile or the severity of my geographic atrophy that I should weigh before considering this drug?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of ocular and systemic adverse events