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

Recruiting now · Phase 1/Phase 2

Conditions studied: Retinal Disease, Macular Degeneration, Age-Related Macular Degeneration, Geographic Atrophy, Eye Diseases

In brief

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.

Key facts

Study ID

NCT06394232

Run by

Eyestem Research Pvt. Ltd.

People needed

54

Starts

2024-06-04

Expected to finish

2030-12-01

Last updated by the study team

2024-09-24

Who can join

Age: 50 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Be medically suitable for immunosuppression therapy in accordance with the requirements of this protocol in the opinion of the Investigator.
• Able to read (or if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) and understand, and willing to sign the informed consent form (ICF)
• Willing to provide signed Informed Consent prior to any procedures being performed at Visit 1, Screening.
• Negative for HIV, HbsAg, HCV, TB
• The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:
• Total GA area must be ≥ 1.25 and ≤ 17.5 mm2 (0.5 and 7 disk areas [DA] respectively)
• The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
• At least one of the lesions has to be sub-foveal.

You may not qualify if…

• 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.
• Have had a prior pars plana vitrectomy in the study eye.
• Have a history of retinal detachment or treatment or surgery for retinal detachment in the study eye.
• Have history of a macular hole in the study eye.
• Have had any other ocular surgery (except cataract) within 2 months or Yttrium Aluminum Garnet (YAG) laser capsulotomy in the study eye in the past 4 weeks.
• Have had a prior trabeculectomy or other filtration surgery in the study eye.
• History of any form of glaucoma in the study eye.
• Patients with ocular pathology, particularly that of retina (other than AMD).
• Have active intraocular inflammation or a history or evidence of uveitis in either eye.
• Have active ocular or periocular infection in either eye, or a history of any ocular or periocular infection within the 2 weeks prior to Visit 1, Screening in either eye.
• Have a history of scleromalacia in either eye.
• Have had previous therapeutic radiation in the study eye.
• Have a history of corneal transplant or corneal dystrophy.
• Have any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
• Have a history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
• Have participated as a subject in any clinical study within 6 months prior to Day 0, Baseline.
• Have a known serious allergy to fluorescein sodium for injection in angiography, Povidone Iodine or any of the other medications required for anesthesia or the subretinal injection procedure.
• Be a female who is pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study at Screening and Baseline.

Where it is running

• Shri Ganapati Netralaya — Jālna, Maharashtra, India (enrolling)
• All India Institute of Medical Sciences — Delhi, New Delhi, India (enrolling)
• L V Prasad Eye Institute — Hyderabad, Telangana, India (enrolling)

Full record on ClinicalTrials.gov

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