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A Repeat-Dose, Open-Label, Two Arm Safety and Efficacy Study of Two Doses of VP-001 Administered Intravitreally in Participants With Confirmed PRPF31 Mutation-Associated Retinal Dystrophy, Including Participants Previously Treated With VP001

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruitingv4 Show 4 more changesShow less
    • Enrollment target: estimated 16 to confirmed 17
    • Primary completion date: Jan 30, 2028 to Mar 8, 2028
    • Study completion date: Mar 3, 2028 to Apr 21, 2028
    • Site details revised at 6 of 6 sites
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 9 more changesShow less
    • Primary completion date: Jun 1, 2027 to Jan 30, 2028
    • Primary endpoint revised
    • Enrollment target: 12 to 16
    • Study completion date: Aug 1, 2027 to Mar 3, 2028
    • Eligibility criteria shortened, about 313 words
    • Secondary endpoints revised (6)
    • Site details revised at 6 of 6 sites
    • Study title expanded, about 9 words
    • Study arms: 4 to 2
  3. Re-verified, no change to tracked fieldsv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 1/2 repeat-dose, open-label, two-arm, parallel group safety and efficacy study of two doses of VP-001 (30 μg and 75 μg) in participants with confirmed PRPF31 mutation-associated retinal dystrophy, including participants previously treated with VP001 in the PLATYPUS Study or WALLABY Study for a minimum of 8 weeks.
Trial Details
NCT Number NCT06852963
Lead Sponsor PYC Therapeutics
Conditions
(from sponsor)		 Retinitis Pigmentosa 11, Retinal Degeneration, Retinal Disease, Eye Diseases Hereditary, Retinal Dystrophies
Related terms Eye Diseases, Hereditary, Retinal Degeneration, Retinal Diseases, Retinal Dystrophies, Retinitis Pigmentosa 11
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov