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

NCT06394232 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-09-24

No results posted yet for this study

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.

Conditions

  • Retinal Disease
  • Macular Degeneration
  • Age-Related Macular Degeneration
  • Geographic Atrophy
  • Eye Diseases

Interventions

DRUG

Eyecyte-RPE™

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

Sponsors & Collaborators

  • Eyestem Research Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2025-04-30
Completion
2030-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06394232 on ClinicalTrials.gov