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Phase 1/2Active, not recruiting

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

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

Sponsor
GenSight Biologics (Industry)
Enrolment
10 enrolled
Conditions
Non-syndromic Retinitis Pigmentosa
Interventions
Gene therapy: GS030-DP AND Medical device: GS030-MD
Ages
adults, older adults
Registry
NCT03326336, EUCTR2017-002204-27

Full record on ClinicalTrials.gov

From the registry

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

Primary outcomes

  • 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

History

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered

Papers citing this trial