Safety & Efficacy of Eyecyte-RPE™ in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration.

Summary

The goal of this clinical study is to evaluate the safety and efficacy of novel stem cell formulation in patients having Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (d-AMD). The main questions it aims to answer are: * Safety and tolerability of the novel stem cell formulation * Potential efficacy of the novel stem cell formulation Participants will receive a single subretinal injection in their study eye and followed up for safety. This is an India only study and the product is developed indigenously.

Timeline

Start

2024-06-04

Primary completion

2025-04

Completion

2030-12

Publications

• Soundararajan L, Surendran H, Patlolla N, Battu R, Stoddard J, Arrizabalaga S, Liu Z, Lingam G, Su X, Ryals RC, Pal R. Allogeneic RPE cell suspension manufactured at scale demonstrating preclinical safety and efficacy led to IND approval. NPJ Regen Med. 2025 Apr 19;10(1):19. doi: 10.1038/s41536-025-00407-0.

Drugs

Indications