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Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery

Study acronym: UDCA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Apr 2027 to May 2027
    • Study completion date: Oct 2027 to Nov 2027
    • Start date changed from estimate of Jul 2024 to Aug 20, 2024
    • Site details revised at 2 of 2 sites
  2. Start date: Apr 2024 to Jul 2024v3
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is indicated for patients with extended rhegmatogenous retinal detachment (RRD) (≥ 2 quadrants) with macula OFF lasting 7 days or less, pseudophakic or aphakic, and scheduled to undergo surgical intervention with vitrectomy and gas tamponade in one of the ophthalmology departments participating in the study. The main objective is to assess the effectiveness of UDCA in visual acuity recovery at 3 months (i.e., the difference between preoperative visual acuity and visual acuity 3 months after surgery) in pseudophakic or aphakic patients who have undergone successful surgical intervention (reattachment of the retina) through vitrectomy and gas tamponade following rhegmatogenous retinal detachment (RRD). 120 patients will be enrolled and randomized in two groups: * the experimental arm "UDCA Group," with oral administration of ursodeoxycholic acid (Ursolvan®) * the control group "Placebo Group," with oral administration of the placebo.
Trial Details
NCT Number NCT06294847
Lead Sponsor Hopital Foch
Conditions
(from sponsor)		 Retinal Detachment
Related terms Retinal Detachment
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov