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

NCT06294847 | Recruiting Phase 3

• 1 other identifier: 2021_0025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Difference in visual recovery (difference between preoperative and postoperative visual acuity) at 3 months postoperative (after a successful reapplication procedure) of at least 6 letters (ETDRS scale) between the two groups (treatment and placebo)

  Difference in visual recovery (difference between preoperative and postoperative visual acuity) at 3 months postoperative (after a successful reapplication procedure) of at least 6 letters (Early Treatment Diabetic Retinopathy Study (ETDRS scale) between the two groups (treatment and placebo). The minimum and maximums valus : Minimum value is 6/95 equivalent in ETDRS letter score read at 4 m = 55. Maximum value is 6/6 equivalement in ETDRS letter score read at 4 m= 115. Higher score mean better ourcome

  3 months

Secondary Outcomes (13)

• Central Nervous Epithelium (CNE) thickness

  1, 3, and 6 months

• Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups.

  1, 3, and 6 months

• Contrast sensitivity measurement using the Clinic CSF2.0 application.

  Day 7, Day 30, Day 60, Day 60, Day 90 and Day 180

• Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, external limiting membrane).

  1, 3 and 6 months

• Retinal thickness measured by OCT (retinal layers and presence of cysts, layer segmentation and measurement in the central 1 and 3 mm in ETDRS quadrants).

  1, 3 and 6 months

Study Arms (2)

Experimental arm: 'UDCA'

EXPERIMENTAL

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.

Drug: Ursolvan

Control arm: 'Placebo'

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Ursolvan 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.

Experimental arm: 'UDCA'

Placebo 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

Control arm: 'Placebo'

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older,
• Scheduled to undergo surgical intervention through vitrectomy,
• Aphakic or pseudophakic patients,
• Experiencing rhegmatogenous retinal detachment affecting 2 quadrants or more,
• Presenting with macula OFF (raised macula) for 7 days or less before the onset of symptoms,
• Has signed a consent form,
• Affiliated with a health insurance plan.

You may not qualify if:

• Patients who have previously undergone vitrectomy for retinal detachment,
• Patients with vitreous hemorrhage or any other associated retinal pathologies,
• Monophthalmic patients,
• Women of childbearing age without effective contraceptive methods,
• Pregnant or lactating women,
• Hypersensitivity to the active substance, bile acids, or any of the excipients in Ursolvan® (see §6.1.1 of this protocol),
• 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),
• Patients with radiopaque calcified gallstones,
• Patients with severe pancreatic disorders,
• Patients with Crohn's disease, ulcerative colitis, or other intestinal diseases that may alter the enterohepatic circulation of bile acids,
• Patients on oral treatment with cholestyramine, colestipol, antacids containing aluminum or magnesium hydroxide and/or smectite (aluminum oxide), cyclosporine, ciprofloxacin, nitrendipine, or dapsone,
• Patients with galactose intolerance, Lapp lactase deficiency, or glucose and galactose malabsorption syndrome (rare hereditary diseases),
• Patients under protective custody.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (2)

Hôpital Cochin

Paris, 75014, France

RECRUITING

Hôpital Foch

Suresnes, 92150, France

RECRUITING

MeSH Terms

Conditions

Retinal Detachment

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Central Study Contacts

BEHAR COHEN Francine

CONTACT

0146252275; f.behar-cohen@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

FR (2)