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
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Gene therapy: GS030-DP AND Medical device: GS030-MDCOMBINATION_PRODUCT
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 Locations
| Facility | City | State | Country |
|---|---|---|---|
| UPMC Eye Center | Pittsburgh | Pennsylvania | United States |
| Centre Hospitalier National d'Ophtalmologie (CHNP) des Quinze-Vingts | Paris | France | |
| Moorfields Eye Hospital NHS Foundation Trust, 162 City Road | London | United Kingdom |