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NCT03326336 · ClinicalTrials.gov registry record · Phase 1
Dose-escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa
A Phase 1 study of Non-syndromic Retinitis Pigmentosa, sponsored by GenSight Biologics.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 3
- Study locations
NCT03326336: Active Phase 1 study of Non-syndromic Retinitis Pigmentosa, sponsored by GenSight Biologics.
NCT03326336 is a Phase 1 study of Non-syndromic Retinitis Pigmentosa that is active but no longer recruiting, run by GenSight Biologics. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03326336, a Phase 1 study of Non-syndromic Retinitis Pigmentosa, is active but no longer recruiting, sponsored by GenSight Biologics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 3
- Study locations
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
Primary Outcome
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.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Gene therapy: GS030-DP AND Medical device: GS030-MD
Study Locations (3)
Other
- Centre Hospitalier National d'Ophtalmologie (CHNP) des Quinze-Vingts - Paris
- Moorfields Eye Hospital NHS Foundation Trust, 162 City Road - London
Pennsylvania
- UPMC Eye Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-09-26 |
| Est. Completion | 2027-10-26 |
| Phase | Phase 1 |
What the registry record for NCT03326336 still lists
NCT03326336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Non-syndromic Retinitis Pigmentosa appearing as the primary indexed condition, and to 1 intervention - of which Gene therapy: GS030-DP AND Medical device: GS030-MD is the first listed.
NCT03326336 reports a single indexed study location in Other, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03326336 about?
NCT03326336 is a clinical study titled "Dose-escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa". 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 subj...
What is the current status of trial NCT03326336?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2018-09-26. Estimated completion is 2027-10-26.
What conditions does trial NCT03326336 study?
This clinical trial studies the following conditions: Non-syndromic Retinitis Pigmentosa.
What interventions are being tested in trial NCT03326336?
The interventions under investigation include: Gene therapy: GS030-DP AND Medical device: GS030-MD (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03326336?
This trial is sponsored by GenSight Biologics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03326336 being conducted?
This trial has 3 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03326336's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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