Safety & Efficacy of Eyecyte-RPE™ in Patients With Geographic Atrophy Secondary to Dry Age-relate… (NCT06394232) | Clinical Trial Compass
RecruitingPhase 1/2
Safety & Efficacy of Eyecyte-RPEâ„¢ in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration.
India54 participantsStarted 2024-06-04
Plain-language 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.
Who can participate
Age range50 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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
✓. Phase 2a ≥ 20/64 (ETDRS letter score 60) in the study eye at Screening.
✓. Vision in the unoperated eye must be better or equal to vision in the study eye.
✓. Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.
✓. Be medically suitable to undergo anesthesia, vitrectomy and subretinal injection in the opinion of the Investigator.
Exclusion criteria
✕. 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.
✕. Have a decrease in BCVA in the study eye due to causes other than GA (e.g., pigment abnormalities, dense sub foveal hard exudates, previous vitreoretinal surgery, retinal dystrophies, non-retinal conditions, visually significant cataract, macular ischemia, etc.).
✕. Have the presence of retinal pigment epithelial tears or rips involving the macula in the study eye at screening.
✕. Have a history or evidence of vitreous hemorrhage in the study eye.
✕. Have a history or clinical evidence of severe diabetic retinopathy, diabetic macular edema, retinal vein occlusion or any other vascular disease affecting the retina in the study eye.