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

NCT ID: NCT06294847

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2027-11-30

Brief Summary

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

Retinal Detachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental arm: 'UDCA'

Experimental arm: 'UDCA': Patients will be treated with ursodeoxycholic acid (UDCA), receiving a single dose of Ursolvan® (10mg/kg) orally within 24 hours before the surgical intervention, followed by a daily dose of 10mg/kg in two divided doses for 30 days.

Group Type: EXPERIMENTAL

Ursolvan

Intervention Type: DRUG

single dose of Ursolvan® (10mg/kg) orally within 24 hours before the surgical intervention, followed by a daily dose of 10mg/kg in two divided doses for 30 days.

Control arm: 'Placebo'

Control arm: 'Placebo': Patients will receive a single dose of placebo orally within 24 hours before the surgical intervention, followed by two doses per day for 30 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients will receive a single dose of placebo orally within 24 hours before the surgical intervention, followed by two doses per day for 30 days

Interventions

Ursolvan

single dose of Ursolvan® (10mg/kg) orally within 24 hours before the surgical intervention, followed by a daily dose of 10mg/kg in two divided doses for 30 days.

Intervention Type: DRUG

Placebo

Patients will receive a single dose of placebo orally within 24 hours before the surgical intervention, followed by two doses per day for 30 days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Cochin

Paris, , France

Site Status: RECRUITING

Hôpital Foch

Suresnes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

BEHAR COHEN Francine

Role: CONTACT

f.behar-cohen@hopital-foch.com

0146252275 ext. +33

Facility Contacts

EYMARD Pauline, Dr

Role: primary

pauline.eymard@aphp.fr

Behar Cohen Francine, Pr

Role: primary

.behar-cohen@hopital-foch.com

01 46 25 22 75

Other Identifiers

2021_0025

Identifier Type: -

Identifier Source: org_study_id