Actively Recruiting
Safety & Efficacy of Eyecyte-RPE™ in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration.
Led by Eyestem Research Pvt. Ltd. · Updated on 2024-09-24
54
Participants Needed
3
Research Sites
338 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety & Efficacy of Eyecyte-RPE™ in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 50 years of age or older at screening
- Diagnosed with Geographic Atrophy secondary to dry Age-related Macular Degeneration
- Best Corrected Visual Acuity (BCVA) in the study eye of 20/200 or worse (ETDRS letter score 64 35) at screening
- For Phase 1: BCVA 64 20/200; for Phase 2a: BCVA 7e 20/64 (ETDRS letter score 60) in the study eye at screening
- Vision in the unoperated eye must be better or equal to the vision in the study eye
- Willing and able to return for all clinic visits and complete study procedures
- Medically suitable for anesthesia, vitrectomy, and subretinal injection as judged by the investigator
- Medically suitable for immunosuppression therapy per protocol requirements
- Able to read or be read to, understand, and willing to sign informed consent
- Negative for HIV, HbsAg, HCV, and TB
- Geographic Atrophy lesion must be between 1.25 and 17.5 mm2 in total area on Fundus Autofluorescence imaging
- Entire GA lesion must be fully visible on macula-centered image and not connected with peripapillary atrophy
- At least one GA lesion must be sub-foveal
You will not qualify if you...
- Evidence of neovascular AMD in either eye
- GA caused by conditions other than AMD, such as Stargardt disease or toxic maculopathies
- Active or inactive choroidal neovascularization due to other causes in the study eye
- Axial myopia greater than -6 diopters or axial length over 26 mm
- Decrease in BCVA in the study eye due to causes other than GA
- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
- History or evidence of vitreous hemorrhage in the study eye
- Severe diabetic retinopathy, diabetic macular edema, retinal vein occlusion, or other vascular retinal disease in the study eye
- Prior pars plana vitrectomy or retinal detachment surgery in the study eye
- History of macular hole in the study eye
- Recent ocular surgery (except cataract) within 2 months or YAG laser capsulotomy within 4 weeks
- Prior trabeculectomy or filtration surgery in the study eye
- History of glaucoma
- Other ocular pathologies, especially retinal diseases other than AMD
- Active intraocular inflammation or history of uveitis
- Active ocular or periocular infection or infection within 2 weeks prior to screening
- History of scleromalacia
- Prior therapeutic radiation in the study eye
- History of corneal transplant or corneal dystrophy
- Any ocular condition that increases risk or interferes with injection or evaluation
- Other diseases or conditions that contraindicate investigational drug use or affect study results
- Participation in any clinical study within 6 months prior to baseline
- Known serious allergy to fluorescein sodium, Povidone Iodine, or medications used in injection procedure
- Female who is pregnant, breastfeeding, or of childbearing potential unwilling to use contraception
- Currently taking aspirin or coagulation modifying drugs that cannot be stopped 7 days before surgery
- Systemic conditions causing immunocompromise such as uncontrolled diabetes or cancer
- Patients with Optic Atrophy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Shri Ganapati Netralaya
Jālna, Maharashtra, India, 431203
Actively Recruiting
2
All India Institute of Medical Sciences
Delhi, New Delhi, India, 110029
Actively Recruiting
3
L V Prasad Eye Institute
Hyderabad, Telangana, India, 500034
Actively Recruiting
Research Team
D
Dr Jogin Desai, MBBS
CONTACT
D
Dr Rajani Battu, MBBS,MS,DNB,FRCS(Edin),PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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