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A STUDY TO EVALUATE THE EFFICACY AND SAFETY OF JCELL IN PATIENTS WITH RETINITIS PIGMENTOSA
Mitul Mehta
A Study On:
- Retinitis Pigmentosa
Status:
- Open
Eligibility
Key Inclusion Criteria:
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
2. Subject age between 18 years and 60 years at time of signing of consent.
3. Willingness of subject to consent to testing for RP gene mutation typing, if not performed
previously with available results
Key Exclusion Criteria:
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.
2. 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).
3. Subject is pregnant or intends to become pregnant less than 12 months after jCell injection.
Interested in joining this trial?
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).
Details
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)
Get in touch with our study team
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