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Promising ROd-cone DYstrophy Gene therapY

Study acronym: PRODYGY
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Primary completion date: Sep 2025 to Feb 2027v6 Show 6 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Sep 2030 to Feb 2031
    • Secondary endpoints revised (12)
    • Site details revised at 6 of 6 sites
    • Eligibility criteria shortened, about 5 words
  2. Minor Study sites: 4 to 6
    • Primary completion date: Mar 2025 to Sep 2025
    • Study completion date: Mar 2029 to Sep 2030
    v5
  3. Minor Study sites: 2 to 4
    • Eligibility criteria expanded, about 68 words
    • Secondary endpoints: 13 to 12
    v4
  4. Minor Start date changed from estimate of Apr 2023 to Apr 12, 2023
    • Study sites revised (2)
    v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2023 to Apr 2023
    • Study sites revised (2)
    • Eligibility criteria expanded, about 3 words
    v2
  6. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a two-step, multicenter, Phase I/II study including an open-label dose-escalation phase (Step 1) and a three-arm, controlled, double-masked, randomized extension phase (Step 2), in subjects with advanced RCD due to a mutation in the RHO, PDE6A, or PDE6B gene (Step 1), or in any RCD-causative gene (Step 2).
Trial Details
NCT Number NCT05748873
Lead Sponsor SparingVision
Conditions
(from sponsor)
Retinitis Pigmentosa
Related terms Cone-Rod Dystrophies, Eye Diseases, Retinal Degeneration, Retinal Diseases, Retinal Dystrophies, Retinitis Pigmentosa
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov