Dose-escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa
Condition(s) studied
Investigational drug(s) / intervention(s)
Gene therapy: GS030-DP AND Medical device: GS030-MD: GS030-Drug Product (GS030-DP) - Recombinant adeno-associated viral vector, derived from serotype 2 (rAAV2.7m8), containing the optimized channelrhodopsin ChrimsonR-tdTomato gene under the control of the ubiquitous CAG promoter (rAAV2.7m8-CAG-ChrimsonR-tdTomato) GS030-Medical Device (GS030-MD) - Visual Interface Stimulating Glasses (that amplify the external visual stimulus to the optogenetically engineered retina)
Study summary
The objective of this study is to evaluate the safety and tolerability of escalating doses of a gene therapy called GS030-DP (injected study treatment) administered via a single intravitreal injection and repeated light stimulation using a medical device called GS030-MD (stimulating glasses) in subjects with documented diagnosis of non-syndromic Retinitis Pigmentosa
Eligibility
Primary outcome measure(s)
- The safety and tolerability of escalating doses of GS030-DP administered via a single IVT and repeated light stimulation using GS030-MD in subjects with non-syndromic Retinitis Pigmentosa — Week 52/Year 1
Safety and tolerability of GS030 treatment at Week 52/Year 1, by assessments based on local and systemic safety issues, specifically those related to IVT of GS030-DP and the subsequent repeated use of GS030-MD, as assessed by incidence of Adverse Events.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| UPMC Eye Center | Pittsburgh | Pennsylvania | |
| Centre Hospitalier National d'Ophtalmologie (CHNP) des Quinze-Vingts | Paris | France | |
| Moorfields Eye Hospital NHS Foundation Trust, 162 City Road | London | United Kingdom |
More GenSight Biologics trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03326336 on ClinicalTrials.gov ↗ ← All trials in France