Using Ursodeoxycholic Acid to Improve Recovery After Retinal Detachment Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of Ursodeoxycholic Acid (UDCA) as an adjuvant treatment for patients undergoing surgery for rhegmatogenous retinal detachment (RRD). The study will enroll 120 patients who are pseudophakic or aphakic and have experienced RRD affecting two or more quadrants with the macula off for 7 days or less. Participants will be randomized into two groups: one receiving UDCA and the other receiving a placebo, with visual acuity recovery assessed three months post-surgery. The primary goal is to determine if UDCA can enhance visual recovery following successful surgical intervention.

Why it matters

Who can join: the full rules

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 of the bile ducts (common bile duct or cystic duct obstruction),
8. Patients with radiopaque calcified gallstones,
9. Patients with severe pancreatic disorders,
10. Patients with Crohn's disease, ulcerative colitis, or other intestinal diseases that may alter the enterohepatic circulation of bile acids,
11. Patients on oral treatment with cholestyramine, colestipol, antacids containing aluminum or magnesium hydroxide and/or smectite (aluminum oxide), cyclosporine, ciprofloxacin, nitrendipine, or dapsone,
12. Patients with galactose intolerance, Lapp lactase deficiency, or glucose and galactose malabsorption syndrome (rare hereditary diseases),
13. Patients participating or in the exclusion period following an interventional research with the use of prohibited medications in this study,
14. Patients under protective custody.

Where it's running

• Hôpital Cochin
  Paris, France Recruiting
• Hôpital Foch
  Suresnes, France Recruiting

Study contacts

• Study coordinator: BEHAR COHEN Francine
• Email: f.behar-cohen@hopital-foch.com
• Phone: 0146252275

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.