Safety and Efficacy of Intravitreal Injection of Human Retinal Progenitor Cells in Adults With Retinitis Pigmentosa
Completed · Phase 2 · Has a placebo group
Conditions studied: Retinitis Pigmentosa
In brief
This study evaluates the changes in visual function at 12 months following a single injection of human retinal progenitor cells compared to sham treated controls in a cohort of adult subjects with RP.
Key facts
- Study ID
- NCT03073733
- Run by
- jCyte, Inc
- People needed
- 84
- Starts
- 2017-03-01
- Expected to finish
- 2020-11-13
- Last updated by the study team
- 2024-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical diagnosis of RP confirmed by ERG and willing to consent to mutation typing, if not already done Best corrected visual acuity (BCVA) 20/80 or worse and no worse than 20/800 Adequate organ function and negative infectious disease screen Female of childbearing potential must have negative pregnancy test and be willing to use medically accepted methods of contraception throughout the study
You may not qualify if…
- Eye disease other than RP that impairs visual function Pseudo-RP, cancer-associated retinopathies History of malignancy or other end-stage organ disease, or any chronic disease requiring continuous treatment with system steroids, anticoagulants or immunosuppressive agents Known allergy to penicillin or streptomycin Treatment with corticosteroids or any investigational or neuroprotectant therapy within 90 days of enrollment Cataract surgery within 3 months prior to enrollment
Where it is running
- Gavin Herbert Eye Inst, Univ Cal Irvine — Irvine, California, United States
- Retina-Vitreous Associates Medical Group — Los Angeles, California, United States
- Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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