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

Last updated: May 12, 2025
Sponsor: Hopital Foch
Overall Status: Active - Recruiting

Phase

3

Condition

Mood Disorders

Macular Degeneration

Retina

Treatment

Ursolvan

Placebo

Clinical Study ID

NCT06294847
2021_0025
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofsymptoms,

  6. Has signed a consent form,

  7. Affiliated with a health insurance plan.

Exclusion

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 inUrsolvan® (see §6.1.1 of this protocol),

  7. Patients with peptic ulcers, acute or chronic liver disease, acute infection orinflammation of the gallbladder or bile ducts, recurrent gallstones, or obstructionof 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 thatmay alter the enterohepatic circulation of bile acids,

  11. Patients on oral treatment with cholestyramine, colestipol, antacids containingaluminum or magnesium hydroxide and/or smectite (aluminum oxide), cyclosporine,ciprofloxacin, nitrendipine, or dapsone,

  12. Patients with galactose intolerance, Lapp lactase deficiency, or glucose andgalactose malabsorption syndrome (rare hereditary diseases),

  13. Patients participating or in the exclusion period following an interventionalresearch with the use of prohibited medications in this study,

  14. Patients under protective custody.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Ursolvan
Phase: 3
Study Start date:
August 20, 2024
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Hôpital Cochin

    Paris, 75014
    France

    Active - Recruiting

  • Hôpital Foch

    Suresnes, 92150
    France

    Active - Recruiting

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