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

Hopital Foch

Status and phase: Enrolling; Phase 3

Conditions: Retinal Detachment

Treatments: Drug: Ursolvan; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06294847

2021_0025

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Experimental arm: 'UDCA'

Experimental group

Description:

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.

Treatment:

Drug: Ursolvan

Control arm: 'Placebo'

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo