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RECRUITING
NCT06394232
PHASE1/PHASE2

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

Sponsor: Eyestem Research Pvt. Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2a Multi-Center, Dose-Escalation Study to Evaluate the Safety & Efficacy of Eyecyte-RPE™ When Administered as a Single-dose Subretinal Injection in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration

Key Details

Gender

All

Age Range

50 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2024-06-04

Completion Date

2030-12

Last Updated

2024-09-24

Healthy Volunteers

No

Interventions

DRUG

Eyecyte-RPE™

Eyecyte-RPE™ is a suspension of hiPSCs (human induced Pluripotent Stem Cells) derived Retinal Pigment Epithelial Cells

Locations (3)

Shri Ganapati Netralaya

Jālna, Maharashtra, India

All India Institute of Medical Sciences

Delhi, New Delhi, India

L V Prasad Eye Institute

Hyderabad, Telangana, India