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RECRUITING
NCT06294847
PHASE3

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

Sponsor: Hopital Foch

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-08-20

Completion Date

2027-11

Last Updated

2025-05-14

Healthy Volunteers

No

Interventions

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

Locations (2)

Hôpital Cochin

Paris, France

Hôpital Foch

Suresnes, France