rsoDeoxyCholic Acid (UDCA) as neuroprotective treatment adjuvant to rhegmatogenous retinal detachment surgery

Phase 1

• Conditions: rhegmatogenous retinal detachment; MedDRA version: 21.0Level: PTClassification code: 10065569Term: Rhegmatogenous retinal detachment Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: CTIS2023-505106-41-01
• Lead Sponsor: Hospital Foch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patient aged 18 or over, scheduled for vitrectomy surgery, Aphake or pseudophake patients,, With rhegmatogenous retinal detachment affecting 2 or more quadrants,, With rhegmatogenous retinal detachment affecting 2 or more quadrants,, Having signed a consent form,, Affiliated with a health insurance

Exclusion Criteria

Patients who have previously undergone vitrectomy for retinal detachment,, Patients suffering from Crohn's disease, haemorrhagic rectocolitis or other intestinal diseases which may alter the enterohepatic circulation of bile acids, Patients undergoing oral treatment with cholestyramine, colestipol, antacids containing aluminium or magnesium hydroxide and/or smectite (aluminium oxide), ciclosporin, ciprofloxacin, nitrendipine or dapsone, Patients with galactose intolerance, Lapp lactate deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases), Patient taking part in or being excluded from interventional research and taking medicines prohibited in the context of this study, Patient placed under protective supervision, Patient with vitreous bleeding or any other associated retinal pathology, Monophthalmic patient, Women of childbearing age without an effective method of contraception, Pregnant or breast-feeding woman,, Hypersensitivity to the active substance, to bile acids or to one of the excipients of Ursolvan®, Patients suffering from peptic ulcer, acute or chronic liver disease, acute infection or inflammation of the gall bladder or bile ducts, repeated biliary colic, occlusion of the bile ducts (bile duct or cystic duct occlusion), Patients with radiopaque calcified gallstones, Patient with severe pancreatic disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified