Safety and Tolerability of hRPC in Retinitis Pigmentosa
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 15
Summary
- Conditions
- Retinitis Pigmentosa
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a first-in-human open label phase I/II dose-escalation study in which participants with retinitis pigmentosa will receive a single uni-ocular subretinal implantation of one of three doses of hRPC. Treated eyes will be carefully monitored for any ocular or systemic adverse events for 2 years....
This is a first-in-human open label phase I/II dose-escalation study in which participants with retinitis pigmentosa will receive a single uni-ocular subretinal implantation of one of three doses of hRPC. Treated eyes will be carefully monitored for any ocular or systemic adverse events for 2 years. Testing will comprise a series of detailed ophthalmic examinations and imaging together with blood testing and systemic evaluations, as necessary. Ophthalmic testing will also be evaluated for any preliminary efficacy signal.
Tracking Information
- NCT #
- NCT02464436
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jason Comander, MD Massachusetts Eye and Ear Infirmary (MEEI) Study Director: Vince Holmes ReNeuron Limited
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