NCT07418177
Not yet recruiting
Phase 1
Study in Human iPSCs-derived Retinal Pigment Epithelium Cells Transplantation for Late-Stage Age-Related Macular Degeneration
The First Affiliated Hospital with Nanjing Medical University1 site in 1 country9 target enrollmentStarted: February 10, 2026Last updated:
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Number of subjects with adverse events
Overview
Brief Summary
Phase I Study of the Safety and Preliminary Efficacy of Human induced pluripotent stem cells-derived Retinal Pigment Epithelial (HiPSC-RPE) Cells Subretinal Transplantation in Late-Stage Age-Related Macular Degeneration(AMD) Patients
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(1)Age ≥50 years and ≤80 years, regardless of gender.
- •(2)Patients with atrophic AMD in the macular area (geographic atrophy \>250μm, involving the foveal center); or stable non-exudative AMD patients who have undergone treatment for wet AMD or have naturally converted to non-exudative AMD (referring to patients with fibrovascular scar formation, who are unresponsive to anti-VEGF treatment, and have no macular edema on OCT and/or no fluorescein leakage on FFA), with a scar diameter not exceeding 6 PD.
- •(3)Best-corrected visual acuity (BCVA) of the study eye ≥5 letters and ≤34 letters (using the ETDRS visual acuity chart).
- •(4)If both eyes meet the criteria, the more severely affected eye will be selected; if the severity is the same in both eyes, the right eye will be designated as the study eye.
- •(5)The patient or their legal representative has signed a written informed consent form.
Exclusion Criteria
- •Ocular Diseases:
- •(1)Vitreous hemorrhage in the study eye within 2 months prior to screening.
- •(2)Presence of a scar, fibrosis, or atrophy involving the fovea in the study eye, or a peripheral scar area greater than 6 PD, indicating severe irreversible visual loss.
- •(3)Presence of pseudoexfoliation syndrome, central retinal vein occlusion, intraocular hemorrhage causing visual loss, rhegmatogenous retinal detachment, macular hole, or choroidal neovascularization due to any cause in the study eye.
- •(4)Presence of a pupillary block defect (APD) in the study eye.
- •(5)Significant media opacity in the study eye that may interfere with visual function assessment or fundus examination.
- •(6)Acute infectious inflammation in either eye during the screening period.
- •(7)Patients with intraocular pressure higher than 25 mmHg despite medical treatment.
- •(8)Monocular blind patients.
- •Ocular Treatments:
Arms & Interventions
HiPSC-RPE cells
Experimental
Subretinal transplantation of HiPSC-RPE cells in experimental eye
Intervention: HiPSC-RPE cells (Biological)
HiPSC-RPE cells
Experimental
Subretinal transplantation of HiPSC-RPE cells in experimental eye
Intervention: Erlotinib (150 mg daily) (Drug)
HiPSC-RPE cells
Experimental
Subretinal transplantation of HiPSC-RPE cells in experimental eye
Intervention: Prednisone (Drug)
Outcomes
Primary Outcomes
Number of subjects with adverse events
Time Frame: Two years following transplantation
Descriptive analysis of frequency and types of adverse events experienced by each subject during the study period.
Secondary Outcomes
- Assessment of visual acuity using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.(From enrollment to the end of visiting at 2 years)
- Assessment of visual function changes-microperimetry(From enrollment to the end of visiting at 2 years)
Investigators
Study Sites (1)
Loading locations...
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