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NCT03777332
Study to Evaluate the Safety of Intravitreal APL-2 in Patients Diagnosed With Geographic Atrophy
Completed
Phase 1
Last updated 10 November 2021
What this trial tests
Phase 1 trial testing PEGCETACOPLAN (APL-2) in Geographic Atrophy in 19 participants. Completed in 1 April 2021.
Timeline
5 November 2018
Primary endpoint
1 April 2021
1 April 2021
1 April 2021
Quick facts
| Lead sponsor | Apellis Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 5 November 2018 |
| Primary completion | 1 April 2021 |
| Estimated completion | 1 April 2021 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- PEGCETACOPLAN (APL-2) — full drug profile →
Conditions studied
- Geographic Atrophy — all drugs for Geographic Atrophy →
Sponsor
Apellis Pharmaceuticals, Inc. — full company profile →
Who can join
60 and older, any sex, with Geographic Atrophy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Safety Assessment of APL-2 in Patients with Geographic Atrophy
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Recent Advances in Age-Related Macular Degeneration Therapies.
Fabre M, Mateo L, Lamaa D, Baillif S, et al · · 2022 · cited 68× · PMID 36014339 · DOI 10.3390/molecules27165089 -
Complement Inhibitors in Age-Related Macular Degeneration: A Potential Therapeutic Option.
Qin S, Dong N, Yang M, Wang J, et al · · 2021 · cited 42× · PMID 34368372 · DOI 10.1155/2021/9945725 -
An update on long-acting therapies in chronic sight-threatening eye diseases of the posterior segment: AMD, DMO, RVO, uveitis and glaucoma.
Ghanchi F, Bourne R, Downes SM, Gale R, et al · · 2022 · cited 35× · PMID 34974541 · DOI 10.1038/s41433-021-01766-w -
A Review of Completed and Ongoing Complement Inhibitor Trials for Geographic Atrophy Secondary to Age-Related Macular Degeneration.
Halawa OA, Lin JB, Miller JW, Vavvas DG. · · 2021 · cited 29× · PMID 34208067 · DOI 10.3390/jcm10122580 -
Targeting the Complement Cascade for Treatment of Dry Age-Related Macular Degeneration.
Patel PN, Patel PA, Land MR, Bakerkhatib-Taha I, et al · · 2022 · cited 15× · PMID 36009430 · DOI 10.3390/biomedicines10081884 -
Pegcetacoplan Treatment for Geographic Atrophy in Age-Related Macular Degeneration Over 36 Months: Data From OAKS, DERBY, and GALE.
Wykoff CC, Holz FG, Chiang A, Boyer D, et al · · 2025 · cited 6× · PMID 40280279 · DOI 10.1016/j.ajo.2025.04.016 -
Efficacy of Continuous Pegcetacoplan Treatment for Subfoveal Geographic Atrophy in Age-Related Macular Degeneration: 36-Month Results from OAKS, DERBY, and GALE Open-Label Extension.
Dhoot DS, Garg SJ, Brown DM, Suñer IJ, et al · · 2026 · PMID 42164977 · DOI 10.2147/opth.s579237
Verify or expand the search:
- PubMed search for NCT03777332
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PEGCETACOPLAN (APL-2)
Trials testing the same drug.
- NCT04770545 — An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic At · Phase 3 · completed
Other recruiting trials for Geographic Atrophy
Currently open trials in the same condition.
- NCT07215234 — A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Se · Phase 1, PHASE2 · recruiting
- NCT06961370 — A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO76693 · Phase 1 · recruiting
- NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
- NCT06769048 — A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) C · Phase 2 · active not recruiting
- NCT06805474 — A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT · recruiting
Other Apellis Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT07214740 — Study to Evaluate a Pegcetacoplan (Syfovre®) Prefilled Syringe · Phase 3 · completed
- NCT06499571 — Geographic Atrophy Long-Terms Outcomes Study · completed
- NCT05067127 — Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex · Phase 3 · completed
- NCT04770545 — An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic At · Phase 3 · completed
- NCT04579666 — MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03777332 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Apellis Pharmaceuticals, Inc.
- Last refreshed: 10 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03777332.
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