Evaluating a stem cell treatment for geographic atrophy from dry age-related macular degeneration.
Official title: A Phase 1/2a Multi-Center, Dose-Escalation Study to Evaluate the Safety & Efficacy of Eyecyte-RPE™ When Administered as a Single-dose Subretinal Injection in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
Run by Eyestem Research Pvt. Ltd. · NCT06394232 · Data updated 2026-11-12
This study is testing a new stem cell treatment for people with geographic atrophy from dry age-related macular degeneration to see if it can help improve their vision.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years to 100 Years |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Eyestem Research Pvt. Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 3 sites (Jālna, Maharashtra and 2 other locations) |
| Status | Recruiting |
| Started | June 4, 2024 |
| Main results expected | April 2025 |
| Study ends | December 2030 |
| Registry record updated | September 24, 2024 |
| Trial ID | NCT06394232 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men and women aged 50 and older with a diagnosis of geographic atrophy secondary to dry age-related macular degeneration and specific visual acuity criteria.
✕Probably not a fit
Patients with better vision in the unoperated eye compared to the study eye or those not suitable for the required medical procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study aims to assess the safety and efficacy of Eyecyte-RPE™, a novel stem cell formulation, in patients suffering from Geographic Atrophy (GA) secondary to dry Age-related Macular Degeneration (d-AMD). Participants will receive a single subretinal injection in their affected eye and will be monitored for safety and tolerability. The study will also evaluate the potential effectiveness of this treatment in restoring vision. Conducted exclusively in India, this trial addresses a significant unmet medical need as there are currently no approved therapies for GA.
Why it matters
Potential benefit: If successful, this treatment could potentially restore vision and improve the quality of life for patients with geographic atrophy.
How similar studies have gone: While stem cell therapies for retinal diseases are being explored, this specific approach is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Men and women ≥ 50 years of age at Screening.
2. Diagnosis of Geographic Atrophy secondary to d-AMD
3. Have Best Corrected Visual Acuity (BCVA) equal to or less than 20/200 Snellen (ETDRS letter score ≤ 35) in the study eye at screening.
1. Phase 1 ≤ 20/200 and
2. Phase 2a ≥ 20/64 (ETDRS letter score 60) in the study eye at Screening.
4. Vision in the unoperated eye must be better or equal to vision in the study eye.
5. Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.
6. Be medically suitable to undergo anesthesia, vitrectomy and subretinal injection in the opinion of the Investigator.
7. Be medically suitable for immunosuppression therapy in accordance with the requirements of this protocol in the opinion of the Investigator.
8. 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)
9. Willing to provide signed Informed Consent prior to any procedures being performed at Visit 1, Screening.
10. Negative for HIV, HbsAg, HCV, TB
11. The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:
1. Total GA area must be ≥ 1.25 and ≤ 17.5 mm2 (0.5 and 7 disk areas \[DA\] respectively)
2. 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.
3. At least one of the lesions has to be sub-foveal.
Exclusion Criteria:
1. Have evidence of neovascular AMD in either eye by clinical examination, fluorescein angiography or optical coherence tomography.
2. 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.
3. 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.
4. Axial myopia greater than -6 diopters or axial length more than 26 mm.
5. 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.).
6. Have the presence of retinal pigment epithelial tears or rips involving the macula in the study eye at screening.
7. Have a history or evidence of vitreous hemorrhage in the study eye.
8. 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.
9. Have had a prior pars plana vitrectomy in the study eye.
10. Have a history of retinal detachment or treatment or surgery for retinal detachment in the study eye.
11. Have history of a macular hole in the study eye.
12. 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.
13. Have had a prior trabeculectomy or other filtration surgery in the study eye.
14. History of any form of glaucoma in the study eye.
15. Patients with ocular pathology, particularly that of retina (other than AMD).
16. Have active intraocular inflammation or a history or evidence of uveitis in either eye.
17. 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.
18. Have a history of scleromalacia in either eye.
19. Have had previous therapeutic radiation in the study eye.
20. Have a history of corneal transplant or corneal dystrophy.
21. 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.
22. 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.
23. Have participated as a subject in any clinical study within 6 months prior to Day 0, Baseline.
24. 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.
25. Be a female who is pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study at Screening and Baseline.
26. Currently receiving aspirin, aspirin containing products and/or any other coagulation modifying drugs which cannot be discontinued 7 days prior to surgery.
27. Have any systemic condition that would qualify the subject as being immunocompromised (e.g., severely uncontrolled diabetes, cancer).
28. Patients with Optic Atrophy
Where it's running
-
Shri Ganapati Netralaya
Jālna, Maharashtra, India Recruiting -
All India Institute of Medical Sciences
Delhi, New Delhi, India Recruiting -
L V Prasad Eye Institute
Hyderabad, Telangana, India Recruiting
Study contacts
- Study coordinator: Dr Jogin Desai, MBBS
- Email: jogin.desai@eyestem.com
- Phone: +91 7676235515
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Understanding Age-Related Macular Degeneration and Its Progression
This study looks at how age-related macular degeneration develops and progresses by comparing people with the condition to healthy individuals, using non-invasive tests and personal feedback.
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Using stem cells to treat retinal and optic nerve damage
This study is testing if using stem cells from your own bone marrow can help improve vision in people with serious eye damage from conditions like age-related macular degeneration and optic nerve problems.
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C.001 for retinal degeneration: a first-in-human dose-escalation safety test
A first-in-human study will test the safety and tolerability of a single subretinal injection of C.001 in adults with retinal diseases involving retinal pigment epithelium degeneration.
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Central microperimetry and radial OCT in geographic atrophy
We will test whether central microperimetry and radial OCT scans can more accurately measure how geographic atrophy progresses toward the fovea in people with or at risk for GA from age-related macular degeneration.
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Tiespectus (MK-8748) versus aflibercept to treat neovascular (wet) age-related macular degeneration
The study will see if tiespectus (MK-8748) works as well as aflibercept for people with newly diagnosed neovascular (wet) age-related macular degeneration.
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Comparing tiespectus (MK-8748) with aflibercept for wet age-related macular degeneration
This study will test whether tiespectus (MK-8748) works as well as aflibercept for people with newly diagnosed neovascular (wet) age-related macular degeneration.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.