Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases

Southwest Hospital, China1 site in 1 country15 target enrollmentMay 2015

ConditionsMacular Degeneration Stargardt's Macular Dystrophy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Macular Degeneration
Sponsor: Southwest Hospital, China
Enrollment: 15
Locations: 1
Primary Endpoint: Number of participants with Treatment-Related Adverse Events [Safety and Tolerability]
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to determine the safety and therapeutic effect of sub-retinal transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in patients with macular degeneration diseases, and explore new treatment modalities for macular degeneration diseases (Age-related macular degeneration and Stargardt's macular dystrophy).

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

December 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Southwest Hospital, China

Responsible Party

Principal Investigator

ZhengQin Yin

Professor

Southwest Hospital, China

Eligibility Criteria

Inclusion Criteria

•Aging from 18 to 75 years
•must have signed informed consent
•At least one visually impaired eye caused by macular degeneration diseases
•Can not be effectively treated with conventional therapies
•Best corrected visual acuity scores between 19 and 73 letter in ETDRs (early treatment diabetic retinopathy ) eye chart , including 19 and 73 (or the equivalent of Snellen eyesight from 20/400 to 20/40)
•Visual loss caused by macular degeneration diseases

Exclusion Criteria

•Eyes with concomitant diseases which will interfere the visual improvement of the study
•Active intraocular inflammation regardless of the grade of severity
•Active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, ophthalmia)
•History of uveitis
•Severe cataract, glaucoma, retinal blood vessels occlusion, retinal detachment, macular hole, vitreous-macula traction
•Iris neovascularization
•Patients who have only one functioning eye, or the best corrected vision of untreated eye scores less than 24 letters in ETDRS chart(corresponding to 20/320 in Snellen chart)
•History of intraocular surgery
•Severe systemic diseases: Stroke, coronary heart disease, angina pectoris, renal insufficiency needing dialysis
•Allergic to sodium fluorescein

Outcomes

Primary Outcomes

Number of participants with Treatment-Related Adverse Events [Safety and Tolerability]

Time Frame: up to 12 months

Patients with Treatment-Related Adverse Events caused by local rejection of implanted cells or systemic immunosuppression treatment

Secondary Outcomes

Flash Electroretinogram (FERG)(up to 12 months)
Visual Field as examined by Static perimetry(up to 12 months)
Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize(up to 12 months)
Amplitude and Latency of Flash Visual Evoked Potentials (FVEP)(up to 12 months)
Multifocal Electroretinogram (MFERG)(up to 12 months)