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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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

Первичные конечные точки

• 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) [Срок оценки: 3 months]

Вторичные конечные точки (12)

• Central Nervous Epithelium (CNE) thickness [Срок оценки: 1, 3, and 6 months]
• Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups. [Срок оценки: 1, 3, and 6 months]
• Contrast sensitivity measurement using the Clinic CSF2.0 application. [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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. [Срок оценки: 1, 3 and 6 months]
• Blood test: liver parameters - AST (SGOT), ALT (SGPT), PAL, and γ-GT. [Срок оценки: 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. [Срок оценки: Day 7 and Day 30]
• Presence of metamorphopsia. [Срок оценки: 1, 3 and 6 months]
• Tolerance and occurrence of adverse events. [Срок оценки: 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. [Срок оценки: 1, 3 and 6 months]
• 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. [Срок оценки: 1 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• Hôpital Cochin — Paris
• Hôpital Foch — Suresnes

Идентификаторы

NCT: NCT06294847 · 2021_0025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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