Actively Recruiting
Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery
Led by Hopital Foch · Updated on 2025-05-14
120
Participants Needed
2
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Scheduled to undergo surgical intervention through vitrectomy
- Aphakic or pseudophakic patients
- Rhegmatogenous retinal detachment affecting 2 quadrants or more
- Macula OFF (raised macula) for 7 days or less before symptoms
- Signed consent form
- Affiliated with a health insurance plan
You will not qualify if you...
- Previous vitrectomy for retinal detachment
- Vitreous hemorrhage or other retinal pathologies
- Monophthalmic patients
- Women of childbearing age without effective contraception
- Pregnant or lactating women
- Hypersensitivity to UDCA or related substances
- Peptic ulcers, liver disease, gallbladder or bile duct inflammation or obstruction
- Radiopaque calcified gallstones
- Severe pancreatic disorders
- Crohn's disease, ulcerative colitis, or other intestinal diseases affecting bile acid circulation
- Taking certain medications including cholestyramine, colestipol, specific antacids, cyclosporine, ciprofloxacin, nitrendipine, or dapsone
- Rare hereditary sugar absorption disorders
- Participating or recently participated in other interventional research with prohibited medications
- Under protective custody
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hôpital Cochin
Paris, France, 75014
Actively Recruiting
2
Hôpital Foch
Suresnes, France, 92150
Actively Recruiting
Research Team
B
BEHAR COHEN Francine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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