Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: Eyecyte-RPEâ?¢: Eyecyte-RPEâ?¢ is a suspension of hiPSCs (human induced Pluripotent Stem Cells)
derived Retinal Pigment Epithelial Cells.
Eyecyte-RPEâ?¢, developed by Eyestem can help t
Sponsors
Eyestem Research Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women greater than or equal to 50 years of age at Screening. 2. Diagnosis of Geographic Atrophy secondary to d-AMD. 3. Have Best Corrected Visual Acuity (BCVA) in the study eye as follows at screening. a. Phase 1 less than or equal to 20/200 and b. Phase 2a greater than or equal to 20/800 and less than or equal to 20/100 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. 10. Participants should have no history and current reactive status for HIV, HBsAg, or HCV infection, as confirmed by laboratory tests. No active signs of TB as confirmed by Chest X-ray. 11. The GA lesion must meet the following criteria as determined by the assessment of Fundus Autofluorescence (FAF) imaging at screening: a. Total GA area must be greater than or equal to 1.25 and less than or equal to 17.5 mm2 (0.5- and 7-disc areas [DA] respectively). b. 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. c. At least one of the lesions must be partially sub-foveal.
Exclusion criteria
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 either eye. (only Study eye will be considered for Phase 1) 4. Axial myopia is greater than -6 diopters or axial length more than 26 mm 5. Have a decrease in BCVA in the either 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.). (only Study eye will be considered for Phase 1) 6. Have the presence of retinal pigment epithelial tears or rips involving the macula in the either eye at screening. (only Study eye will be considered for Phase 1) 7. Have a history or evidence of vitreous hemorrhage in the either eye. (only Study eye will be considered for Phase 1) 8. Have history or clinical evidence of severe diabetic retinopathy, diabetic macular edema, retinal vein occlusion, or any other vascular disease affecting the retina in the either eye. (only Study eye will be considered for Phase 1) 9. Have had a prior pars plana vitrectomy in the either eye. (only Study eye will be considered for Phase 1) 10. Have a history of retinal detachment or surgery for retinal detachment in the either eye. (only Study eye will be considered for Phase 1) 11. Have history of a macular hole in either eye. (only Study eye will be considered for Phase 1) 12. Have had any other ocular surgery within 2 months or Yttrium Aluminum Garnet (YAG) laser capsulotomy in the either eye in the past 4 weeks. (only Study eye will be considered for Phase 1) 13. Have had a prior trabeculectomy or other filtration surgery in the either eye. (only Study eye will be considered for Phase 1) 14. History of uncontrolled glaucoma in the either eye. (History of any form of glaucoma in study eye will be considered for Phase 1) 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 the 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 in either eye. 18. Have a history of scleromalacia in either eye. 19. Have had previous therapeutic radiation in the either eye. (only Study eye will be considered for Phase 1) 20. Have a history of corneal transplants or corneal dystrophy. 21. Have any concurrent ocular conditions in the either 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. (only Study eye will be considered for Phase 1) 22. Have a history of other diseases, physical examination findings, or clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint - Phase 1 a Fundus Autofluorescence Phase 2 a BCVATimepoint: Phase 1 At Screening (â?¥ 28 days), During Active Follow-up on the following visits Days- 1, 7, 14, 28, 42, 56, 70, 84, 120, 150 and 180 During Safety Follow-up on the following visits Months- 12, 18, 24, 36, 48 and 60 Phase 2 At Screening (â?¥ 28 days), During Active Follow-up on the following visits Days- 1, 7, 28, 56,84, 120, 150 and 180 During Safety Follow-up on the following visits Months- 9,12, 15,18,21, 24, 36, 48 and 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1 Secondary Efficacy Endpoints b. BCVA ETDRS c. Fundus Photography d. SD-OCT e. Microperimetry Timepoint: Phase 1 b. BCVA ETDRS Screening (â?¥ 28 days), Active Follow-up Days- 1, 7, 14, 28, 42, 56, 70, 84, 120, 150 & 180 Safety Follow-up Months- 12, 18, 24, 36, 48 & 60 c. Fundus Photography, d. SD-OCT & e. Microperimetry Screening (â?¥ 28 days), Active Follow-up Days- 1, 7, 14, 28, 42, 56, 70, 84, 120, 150 & 180 Safety Follow-up Months- 12, 18, 24, 36, 48 and 60 ;Phase 1 f. NEI VFQ-25 Quality of Life scoreTimepoint: Phase 1 Screening (â?¥ 28 days), Active Follow-up Day 180 Safety Follow-up Months- 12, 18, 24, 36, 48 & 60 ;Phase 2 Secondary Efficacy Endpoints b. SD-OCT c. Fundus Autofluorescence (FAF) d. Fundus Photography e. Microperimetry Timepoint: Phase 2 b. SD-OCT, d. Fundus Photography At Screening (â?¥ 28 days), Active Follow Days- 1,7,28,56,84,120,150 & 180 Safety Follow-up Months- 9,12,15,18,21,24,36,48 & 60 c. Fundus Autofluorescence (FAF) At Screening (â?¥ 28 days), Active Follow-up Days-7,28,56,84,120,150 & 180 Safety Follow-up Months- 9,12,15,18,21,24,36,48 & 60 e. Microperimetry Screening (â?¥ 28 days), Active Follow-up Days 84 & 180 Safety Follow-up Months- 9,12, 15,18,21, 24, 36, 48 & 60 ;Phase 2 f. NEI VFQ-25 Quality of Life scoreTimepoint: Phase 2 Screening (â?¥ 28 days), Active Follow-up Days 84, & 180 Safety Follow-up Months- 9,12, 15,18,21, 24, 36, 48 & 60 | — |
Countries
India
Contacts
Public ContactDr Jogin Desai
Eyestem Research Pvt. Ltd.
Outcome results
None listed