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ACTIVE NOT RECRUITING
NCT03326336
PHASE1/PHASE2

Dose-escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa

Sponsor: GenSight Biologics

View on ClinicalTrials.gov

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

Official title: A Phase 1/2a, Open-Label, Non-Randomized, Dose-Escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2018-09-26

Completion Date

2027-10-26

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

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)

Locations (3)

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