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Study in Human iPSCs-derived RPE Cells Transplantation for Late-Stage AMD

ConditionAMD - Age-Related Macular Degeneration
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50-80
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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.

Disqualifiers

(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.

Trial design

Design model

Single group

Treatments tested in this trial

  • HiPSC-RPE cells

    Biological/Vaccine

    HiPSC-RPE cells transplantation directly into the subretinal space of one eye (experimental eye) in a single transplant procedure

  • Erlotinib (150 mg daily)

    Drug

    Subjects began oral administration of erlotinib one day before surgery at a dose of 150 mg once daily for a total duration of 1 month.

  • Prednisone

    Drug

    Prednisone was initiated 3 days prior to surgery at a dose of 30 mg/day (5 mg per tablet, 6 tablets daily) and continued for 6 weeks, with the dose tapered by one tablet per week until discontinuation.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: HiPSC-RPE cellsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of subjects with adverse events

Descriptive analysis of frequency and types of adverse events experienced by each subject during the study period.

Time frame
Two years following transplantation

Secondary outcomes

1

Assessment of visual acuity using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.

Visual acuity will be assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart. Scores range from 0 to 100 letters, where higher scores represent better visual acuity.

Time frame
From enrollment to the end of visiting at 2 years
2

Assessment of visual function changes-microperimetry

Microperimetry results within 2 degrees and 4 degrees.

Time frame
From enrollment to the end of visiting at 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: