RST-001 Phase I/II Trial for Advanced Retinitis Pigmentosa
- Registration Number
- NCT02556736
- Lead Sponsor
- AbbVie
- Brief Summary
Currently enrolling a total of 12 patients for Phase 2a of the study: 6 patients must have VA of no-better-than hand motion in the study eye, and 6 patients must have VA in the study eye to range from no-worse-than count fingers to 20/200 vision.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 1 RST-001 Single intravitreal injection of RST-001
- Primary Outcome Measures
Name Time Method Number of Participants With Any Grade 3 or Greater Adverse Event (AE) Considered Related to RST-001. Baseline (Day 1) to 6 Months The U.S. Dept. of Health and Human Services' Common Terminology Criteria for Adverse Events grades AEs from 1 (Mild) to 5 (Death related to AE).
Grade 3 is defined as "Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Activities of Daily Living (ADL)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Retina Foundation of the Southwest
🇺🇸Dallas, Texas, United States
Duke Eye Center
🇺🇸Durham, North Carolina, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
University of California, San Francisco- Dept. of Ophthalmology
🇺🇸San Francisco, California, United States