NCT07418177

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
32mo left

Started Feb 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

January 9, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 18, 2026

Status Verified

October 1, 2025

Enrollment Period

2.3 years

First QC Date

January 9, 2026

Last Update Submit

February 11, 2026

Conditions

AMD - Age-Related Macular Degeneration

Keywords

Late-Stage Age-related Macular DegenerationAge-Related Macular DegenerationMacular DegenerationAMD

Outcome Measures

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.

    Two years following transplantation

Secondary Outcomes (2)

  • 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

Study Arms (1)

HiPSC-RPE cells

EXPERIMENTAL

Subretinal transplantation of HiPSC-RPE cells in experimental eye

Biological: HiPSC-RPE cellsDrug: Erlotinib (150 mg daily)Drug: Prednisone

Interventions

HiPSC-RPE cellsBIOLOGICAL

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

HiPSC-RPE cells
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.

HiPSC-RPE cells
PrednisoneDRUG

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.

HiPSC-RPE cells

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • 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:
  • (9)The study eye has undergone focal/grid laser photocoagulation within 3 months prior to screening.
  • (10)The study eye has undergone the following intraocular surgeries or laser treatments within 3 months prior to screening, such as macular translocation, cataract surgery, glaucoma filtration surgery, verteporfin photodynamic therapy, transpupillary thermotherapy, foveal laser photocoagulation, vitrectomy, optic nerve decompression, or optic nerve sheath decompression.
  • (11)Any eye has received anti-angiogenic drug treatment (including any anti-VEGF drugs) within 3 months prior to screening (e.g., Aflibercept \[Eylea®\], Ranibizumab \[Lucentis®\], Bevacizumab \[Avastin®\]).
  • Systemic Diseases, Treatments, and Other Conditions:
  • (12)Patients with an allergic reaction or history of allergy to sodium fluorescein and indocyanine green, a history of allergy to protein products used for treatment or diagnosis, and patients with allergies to two or more drugs and/or non-drug factors, or those currently suffering from allergic diseases.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Erlotinib HydrochloridePrednisone

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Songtao Yuan, M.D.

    The First Affiliated Hospital with Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Songtao Yuan, M.D.

CONTACT

+86159-5108-8899songtaoyuan@njmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

February 18, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 18, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)