Using Ursodeoxycholic Acid to Improve Recovery After Retinal Detachment Surgery

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

This study is testing if a medication called Ursodeoxycholic Acid can help people recover their vision better after surgery for a specific type of retinal detachment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hopital Foch (Academic / other)
• Locations: 2 sites (Paris and 1 other locations)
• Trial ID: NCT06294847 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for vitrectomy due to extensive rhegmatogenous retinal detachment.

Not a fit: Patients who have previously undergone vitrectomy for retinal detachment or have other significant retinal pathologies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve visual recovery for patients undergoing surgery for retinal detachment.

How similar studies have performed: While the use of UDCA in this context is novel, similar studies exploring neuroprotective agents in retinal surgery have shown promising results.

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 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 this trial is running

Paris and 1 other locations

• Hôpital Cochin — Paris, France (Recruiting)
• Hôpital Foch — Suresnes, France (Recruiting)

Study contacts

• Study coordinator: BEHAR COHEN Francine

Conditions Retinal Detachment