Study in Human iPSCs-derived RPE Cells Transplantation for Late-Stage AMD (NCT07418177) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Study in Human iPSCs-derived RPE Cells Transplantation for Late-Stage AMD
China9 participantsStarted 2026-02-10
Plain-language 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
Who can participate
Age range50 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Number of subjects with adverse events
Timeframe: Two years following transplantation
Trial details
NCT IDNCT07418177
SponsorThe First Affiliated Hospital with Nanjing Medical University