NCT06294847

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Retinal Detachment

Interventions

Type	Name	Description
DRUG	Ursolvan	single dose of Ursolvan® (10mg/kg) orally within 24 hours before the surgical intervention, followed by a daily dose of 10mg/kg in two divided doses for 30 days.
DRUG	Placebo	Patients will receive a single dose of placebo orally within 24 hours before the surgical intervention, followed by two doses per day for 30 days

Timeline

• Start date: 2024-08-20
• Primary completion: 2027-05-01
• Completion: 2027-11-01
• First posted: 2024-03-06
• Last updated: 2025-05-14

Locations

2 sites across 1 country: France