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An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects with Geographic Atrophy Secondary to AMD
EU CTIS ID: 2024-512945-18-00
What this study is testing
To evaluate the long-term safety of IVT-injected pegcetacoplan
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ocular-specific inclusion criteria apply to the study eye. 1. Participated in APL2-103 (NCT03777332) or completed the treatment at month 24 of either APL2-303 (Derby, NCT03525613) or APL2-304 (Oaks, NCT03525600). Specifically, for the APL2-303 and APL2-304 studies, the following criterion also applies: a. Participants who did not permanently discontinue treatment but missed the month 24 visit are also eligible to participate in this extension study; however, to be eligible, these participants must be screened within 60 days from the last day of the expected month 24 visit window for the antecedent study.
- 2. Clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the investigator. Inclusion criterion #2 applies to the fellow eye.
- 3. Female participants must be: a. Women of nonchildbearing potential, or b. Women of childbearing potential (WOCBP), defined as any women who have experienced menarche and who are not permanently sterile or postmenopausal, must have a negative serum pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and 90 days after their last dose of pegcetacoplan, and refrain from breastfeeding for the duration of the study.
- 4. Males with female partners of childbearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study and for 90 days after their last dose of pegcetacoplan.
- 5. Willing and able to give informed consent and to comply with the study procedures and assessments.
You likely can't join if
- Ocular-specific exclusion criteria apply to the study eye. 1. Participants who permanently discontinued the study drug prior to month 24 in the APL2-304 or APL2-304 studies and only for safety assessments. Temporary pause of the study drug is not exclusionary.
- 2. Presence of an active ocular disease that, in the opinion of the investigator, compromises or confounds visual function, including, but not limited to, macular hole or other macular diseases (eg, clinically significant epiretinal membrane). Benign conditions in the opinion of the investigator such as peripheral retinal dystrophy are not exclusionary. Exclusion criteria 2 and 3 apply to the fellow eye.
- 3. Any contraindication to IVT injection including current ocular or periocular infection. Exclusion criteria 2 and 3 apply to the fellow eye.
- 4. Medical or psychiatric condition that, in the opinion of the investigator, is clinically significant and not suitable for study participation or make consistent follow-up over the 36-month treatment period unlikely.
- 5. Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to pegcetacoplan or any of the excipients in pegcetacoplan solution.
- 6. Pregnancy, breastfeeding, or positive pregnancy test.
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- United States
- Israel
- Canada
- Brazil
- United Kingdom
- Australia
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; United States; Israel; Canada; Brazil; United Kingdom and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.