drugset / Trial / NCT04435366
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
RandomizedParallel-groupDouble-blindTreatment
Summary
The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)
Timeline
- Start
- 2020-06-22
- Primary completion
- 2022-07-25
- Completion
- 2023-08-22
Outcome
Met primary endpoint
registry analysis (superiority test); Avacincaptad Pegol vs Sham; p = 0.0064; Least Squares Mean Difference 0.056 (95% CI 0.016 to 0.096); MMRM; NCT04435366 ↗
registry analysis (superiority test); Avacincaptad Pegol vs Sham; p = 0.0165; Least Squares Mean Difference 0.362 (95% CI 0.066 to 0.657); MMRM; NCT04435366 ↗
release “IZERVAY met its primary endpoint in the GATHER1 ( NCT02686658 ) clinical trial and the GATHER2 ( NCT04435366 ) clinical trial” astellas.com ↗
Publications
- Khanani AM, Danzig CJ, Heier JS, Jaffe GJ, Kaiser PK, Lally DR, Patel SS, Vajzovic L, Weng CY, Patel H, Clark J, Desai D, Luo D, Henry E, Holz FG; GATHER2 Trial Investigators. Avacincaptad Pegol for Geographic Atrophy Secondary to Age-Related Macular Degeneration: Two-Year Efficacy and Safety Results from the GATHER2 Phase 3 Trial. Ophthalmology. 2026 Apr;133(4):451-465. doi: 10.1016/j.ophtha.2025.12.011. Epub 2025 Dec 15.
- Khanani AM, Patel SS, Staurenghi G, Tadayoni R, Danzig CJ, Eichenbaum DA, Hsu J, Wykoff CC, Heier JS, Lally DR, Mones J, Nielsen JS, Sheth VS, Kaiser PK, Clark J, Zhu L, Patel H, Tang J, Desai D, Jaffe GJ; GATHER2 trial investigators. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1449-1458. doi: 10.1016/S0140-6736(23)01583-0. Epub 2023 Sep 8.
- Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avacincaptad Pegol | Aptamer | 2 mg | Intravitreal |