Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Summary
The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
Timeline
- Start
- 2015-12-15
- Primary completion
- 2019-09-26
- Completion
- 2020-04-23
Outcome
Met primary endpoint
registry analysis (other test); Zimura 2 mg [Part 1 & Part 2 Combined] vs Sham [Part 1 & Part 2 Combined]; p = 0.0072 NCT02686658 ↗
registry analysis (other test); Zimura 4 mg [Part 2] vs Sham [Part 2]; p = 0.0051 NCT02686658 ↗
paper The reduction in the mean rate of GA growth (square root transformation) over 12 months was 27.4% (P = 0.0072) PMID 32882310 ↗
release “IZERVAY met its primary endpoint in the GATHER1 ( NCT02686658 ) clinical trial and the GATHER2 ( NCT04435366 ) clinical trial” astellas.com ↗
release “IZERVAY met its primary endpoint in the GATHER1 ( NCT02686658 ) clinical trial” astellas.com ↗
Publications
- Results Jaffe GJ, Westby K, Csaky KG, Mones J, Pearlman JA, Patel SS, Joondeph BC, Randolph J, Masonson H, Rezaei KA. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021 Apr;128(4):576-586. doi: 10.1016/j.ophtha.2020.08.027. Epub 2020 Sep 1.
- Corradetti G, Karamat A, Srinivas S, Lindenberg S, Velaga SB, Corvi F, Attiku Y, Nittala MG, Desai D, Zhu L, Abulon D, Sadda SR. Progression to complete retinal pigment epithelium and outer retinal atrophy (cRORA): post hoc analysis of the GATHER1 trial. Graefes Arch Clin Exp Ophthalmol. 2025 Mar;263(3):669-677. doi: 10.1007/s00417-024-06676-7. Epub 2024 Nov 14.
- 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 | 1 mg | Intravitreal |
| Subject | Avacincaptad Pegol | Aptamer | 2 mg | Intravitreal |
| Subject | Avacincaptad Pegol | Aptamer | 4 mg | Intravitreal |