NCT06294847 Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery
| NCT ID | NCT06294847 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hopital Foch |
| Condition | Retinal Detachment |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-08-20 |
| Primary Completion | 2027-05 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years or older, 2. Scheduled to undergo surgical intervention through vitrectomy, 3. Aphakic or pseudophakic patients, 4. Experiencing rhegmatogenous retinal detachment affecting 2 quadrants or more, 5. Presenting with macula OFF (raised macula) for 7 days or less before the onset of symptoms, 6. Has signed a consent form, 7. Affiliated with a health insurance plan. Exclusion Criteria: 1. Patients who have previously undergone vitrectomy for retinal detachment, 2. Patients with vitreous hemorrhage or any other associated retinal pathologies, 3. Monophthalmic patients, 4. Women of childbearing age without effective contraceptive methods, 5. Pregnant or lactating women, 6. Hypersensitivity to the active substance, bile acids, or any of the excipients in Ursolvan® (see §6.1.1 of this protocol), 7. Patients with peptic ulcers, acute or chronic liver disease, acute infection or inflammation of the gallbladder or bile ducts, recurrent gallstones, or obstruction