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Safety and Efficacy Study of NGGT001 in Bietti Crystalline Corneoretinal Dystrophy

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later May 29, 2024 → Nov 25, 2024
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from Xiamen Ophthalmology Center Affiliated to Xiamen University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 29, 2024 to Nov 25, 2024v2 Show 6 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 6 → 11 participants
    • Study completion pushed from May 29, 2028 to Nov 25, 2028
    • Trial arms changed: 2 → 4
    • Secondary endpoints expanded, about 22 words
    • Publications: details revised at 1 of 1 entry
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Evaluate the safety and tolerability of NGGT001 subretinal injection for the treatment of crystalline retinal degeneration (BCD)
Trial Details
NCT Number NCT06302608
Lead Sponsor Xiamen Ophthalmology Center Affiliated to Xiamen University
Conditions
(from sponsor)		 Bietti's Crystalline Dystrophy
Related terms Bietti Crystalline Dystrophy
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov