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A STUDY TO EVALUATE THE EFFICACY AND SAFETY OF JCELL IN PATIENTS WITH RETINITIS PIGMENTOSA

UCI Specialty Area: Ophthalmology
Principal Investigator: Mitul Mehta
Official Title: A RANDOMIZED, MASKED, PLACEBOCONTROLLED ADAPTIVE PHASE 2/3 TRIAL OF THE EFFICACY AND SAFETY OF A SINGLE INTRAVITREAL INJECTION OF JCELL (FAMZERETCEL) FOR THE TREATMENT OF RETINITIS PIGMENTOSA (RP).
A Study On:
Retinitis Pigmentosa

Study Description

A Randomized, Masked, Sham-Controlled, Phase 2 Trial of the Safety of a Single Intravitreal Injection of

jCell (famzeretcel) for the Treatment of Retinitis Pigmentosa (RP)

Eligibility

  1. Clinical diagnosis of RP supported by at least 2 of the following clinical findings:

Loss of peripheral vision on formal visual field testing

Symptoms of night blindness or difficulty adjusting to dim light

OCT outer retinal atrophy consistent with RP

  1. Subject age between 18 years and 60 years at time of signing of consent.
  1. Willingness of subject to consent to testing for RP gene mutation typing, if not performed

previously with available results

Key

  1. Participation in any clinical trial of a drug intervention within the last 6 months, with the

exception of a N-acetyl cysteine (NAC) study.

  1. History of ocular treatment with any non-approved, experimental, investigational or

neuroprotectant therapy (systemic, topical, intravitreal) or device in either eye, including

previous jCyte clinical trials. Individuals with a history of N-acetyl cysteine (NAC) treatment

may take part in the study following a 7-day washout period (prior to Baseline testing).

  1. Subject is pregnant or intends to become pregnant less than 12 months after jCell injection.
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
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