A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Summary

This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.

Timeline

Start

2020-12-08

Primary completion

2023-01-04

Completion

2023-01-04

Publications

• Pearlman JA, Sheth VS, Khanani AM, Indjeian VB, Brunstein F, Kuruvilla D, Maia M, Dere R, Ma L, Chen H, Datta S, Willis JR, Wiley HE. Phase I Study of the Anti-interleukin 33 Fragment Antigen-Binding Region RO7303359 in Geographic Atrophy Secondary to Age-Related Macular Degeneration. Ophthalmol Sci. 2025 Apr 20;5(5):100800. doi: 10.1016/j.xops.2025.100800. eCollection 2025 Sep-Oct.

Drugs

Indications