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

Study acronym: PIONEER
StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv12
  2. Primary completion date: Dec 2022 to Oct 26, 2027v11 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 15 to confirmed 10
    • Study completion date: Dec 2025 to Oct 26, 2027
    • Secondary endpoints revised (7)
    • Study description expanded, about 71 words
    • Site details revised at 3 of 3 sites
    • Eligibility criteria shortened, about 2 words
  3. Primary completion date: Dec 2021 to Dec 2022v10
  4. Enrollment target: 18 to 15v9
  5. Primary completion date: Sep 2020 to Dec 2021
    • Study completion date: Jan 2025 to Dec 2025
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 1 of 3 sitesv7
  2. Re-verified, no change to tracked fieldsv6
  3. Site details revised at 1 of 3 sitesv5
  4. Site details revised at 1 of 3 sitesv4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Start date changed from estimate of May 2018 to Sep 26, 2018
    • Study sites: 0 to 3
    • Primary completion date: Jun 2020 to Sep 2020
    • Study completion date: May 2024 to Jan 2025
    • Eligibility criteria expanded, about 54 words
  6. Start date: Jan 2018 to May 2018v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT03326336
Lead Sponsor GenSight Biologics
Conditions
(from sponsor)		 Non-syndromic Retinitis Pigmentosa
Related terms Cone-Rod Dystrophies, Eye Diseases, Eye Diseases, Hereditary, Retinal Degeneration, Retinitis Pigmentosa
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov