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

Launched by HOPITAL FOCH · Feb 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Ursodeoxycholic Acid (UDCA) to see if it can help improve vision after surgery for a specific type of eye problem known as rhegmatogenous retinal detachment (RRD). This condition occurs when the retina, the light-sensitive layer at the back of the eye, gets pulled away from its normal position, which can severely affect vision. The trial will involve patients who are scheduled for surgery to fix this issue, specifically those aged 18 and older who have RRD affecting two or more quadrants of the retina and have experienced a macula-off condition for 7 days or less.

Participants will be randomly divided into two groups: one will receive UDCA, while the other will receive a placebo (a dummy treatment with no active ingredients). The main goal is to compare how well participants recover their vision three months after surgery. If you or someone you know has RRD and meets the eligibility criteria, this trial may be a potential option to consider. It's important to note that certain medical conditions and treatments could exclude someone from participating, so discussing eligibility with a healthcare provider is crucial.

Gender

ALL

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.