Safety and Efficacy of Autologous Transplantation of iPSC-RPE in the Treatment of Macular Degeneration

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-75
SponsorBeijing Tongren Hospital

About this trial

This project intends to perform autologous transplantation of induced pluripotent stem cell-derived retinal pigment epithelium (iPSC-RPE). The clinical-grade RPE will be transplanted into subretinal space to treat refractory age-related macular degeneration. The efficacy and safety of RPE transplants to treat macular degeneration will be monitored and analyzed with results from EDTRS, BCVA, OCT, ERG, microperimetry, and fluorescein angiography, before and after the treatment.

Eligibility criteria

Qualifiers

Aged 50-75 years;

Clinical diagnosis is consistent with the definition of late dry AMD in the age-related eye disease study (AREDS), with one or more >250 um geographic atrophy in the fovea;

Clinical diagnosis is wet AMD, but no obvious efficacy after conventional treatment;

The BCVA of the target eye will be 0.05 to 0.3;

Disqualifiers

One-eyed subjects;

Macular atrophy caused by other diseases in addition to AMD;

Suffer from retinitis pigmentosa, choroidal retinitis, central serous choroiditis, diabetic retinopathy, or other retinal vascular and degenerative diseases besides AMD;

Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, optic neuropathy, and other ocular histories;

Trial design

Treatments tested in this trial

  • Autologous iPSC-derived RPE

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators