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NCT Number: NCT06294847

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

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.

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Cochin, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 participating or in the exclusion period following an interventional research with the use of prohibited medications in this study,
  • Patients under protective custody.

Treatment and study plan

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.

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

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)

    Time frame: 3 months

    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

Secondary outcomes

  1. Central Nervous Epithelium (CNE) thickness

    Time frame: 1, 3, and 6 months

    Central Nervous Epithelium (CNE) thickness, measured by SD-OCT (Spectral-Domain Optical Coherence Tomography), within the central 1mm compared to the contralateral eye in the treated group versus the placebo group (measurement adjusted to the contralateral eye to account for interindividual variability) at 1, 3, and 6 months.

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

    Time frame: 1, 3, and 6 months

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

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

    Time frame: Day 7, Day 30, Day 60, Day 60, Day 90 and Day 180

    Contrast sensitivity measurement using the Clinic CSF2.012 application (Contrast sensitivity function 2.0 application).

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

    Time frame: 1, 3 and 6 months

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

  5. 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).

    Time frame: 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).

  6. Number of macular cones and retinal pigment epithelium (RPE) cells measured by Adaptive Optics at 1, 3, and 6 months with the "Cellularis" device that allows visualization of cones and RPE.

    Time frame: 1, 3 and 6 months

    Number of macular cones and retinal pigment epithelium (RPE) cells measured by Adaptive Optics at 1, 3, and 6 months with the "Cellularis" device that allows visualization of cones and RPE.

  7. Blood test: liver parameters - AST (SGOT), ALT (SGPT), PAL, and γ-GT.

    Time frame: Day 7 and Day 30

    Blood test: liver parameters - AST (SGOT), ALT (SGPT), PAL, and γ-GT.

  8. Evolution of the best visual acuity measured at Day 0, Day 7, Day 30, Day 60, Day 90, and Day 180: Difference between the treated and placebo groups in the progression curves of visual acuity.

    Time frame: Day 7 and Day 30

    Evolution of the best visual acuity measured at Day 0, Day 7, Day 30, Day 60, Day 90, and Day 180: Difference between the treated and placebo groups in the progression curves of visual acuity.

  9. Presence of metamorphopsia.

    Time frame: 1, 3 and 6 months

    Presence of metamorphopsia.

  10. Tolerance and occurrence of adverse events.

    Time frame: 1, 3 and 6 months

    Tolerance and occurrence of adverse events.

  11. National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) quality of life questionnaire before surgery, at ±7 days postoperative, and at 3 months postoperative.

    Time frame: 1, 3 and 6 months

    National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) quality of life questionnaire before surgery, at ±7 days postoperative, and at 3 months postoperative.

  12. Correlation between protein levels, bile acids, or other molecular markers in ocular and/or blood fluids and functional and anatomical ocular parameters pre- and post-operatively at different observation times.

    Time frame: 1 month

    Correlation between protein levels, bile acids, or other molecular markers in ocular and/or blood fluids and functional and anatomical ocular parameters pre- and post-operatively at different observation times.

  13. Correlation between the effective duration of treatment and functional and anatomical outcomes at different observation times.

    Time frame: 6 months

    Correlation between the effective duration of treatment and functional and anatomical outcomes at different observation times.

Study contacts

Contact information is provided by the study sponsor or research team.

BEHAR COHEN Francine

CONTACT

[email protected]

0146252275 ext. +33

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: UDCA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2024
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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