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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50-100
SponsorEyestem Research Pvt. Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Men and women ≥ 50 years of age at Screening.

Diagnosis of Geographic Atrophy secondary to d-AMD

Have Best Corrected Visual Acuity (BCVA) equal to or less than 20/200 Snellen (ETDRS letter score ≤ 35) in the study eye at screening.

Phase 1 ≤ 20/200 and

Disqualifiers

Have evidence of neovascular AMD in either eye by clinical examination, fluorescein angiography or optical coherence tomography.

Have GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Chloroquine maculopathy in either eye.

Have any evidence of active or inactive choroidal neovascularization (CNV) due to other causes such as ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, uveitis, punctate inner choroidopathy, or multifocal choroiditis in the study eye.

Axial myopia greater than -6 diopters or axial length more than 26 mm.

Trial design

Treatments tested in this trial

  • Eyecyte-RPE™

Treatment groups

54 Participants
are divided into 3 treatment groups

Sponsors and collaborators