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.
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
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.
Sequential
Eyecyte-RPE™
DrugEyecyte-RPE™ is a suspension of hiPSCs (human induced Pluripotent Stem Cells) derived Retinal Pigment Epithelial Cells
Fundus Autofluorescence-
Overall change in the geographic atrophy (GA) lesion area of the study eye over time using Fundus Autofluorescence (FAF)
Best Corrected Visual Acuity (BCVA)-Mean change from baseline in BCVA score in study eye and fellow eye.
Change from baseline over time in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The BCVA score (in letter units) will be reported.
Spectral-Domain Optical Coherence Tomography (SD-OCT)-Mean change from baseline in the Geographic Atrophy (GA) area in study eye and fellow eye
Overall change in the GA lesion area of the study eye over time using SD-OCT
Fundus Photography- Changes between study eye and fellow eye
Correlation assessment between quantitative metrics derived from Color fundus photography images
Microperimetry-Mean change from baseline in mean sensitivity
Change from initial assessment over time in retinal sensitivity, as assessed by Microperimetry (MP)
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