2023-505106-41-01招募中3 期
UrsoDeoxyCholic Acid (UDCA) as neuroprotective treatment adjuvant to rhegmatogenous retinal detachment surgery
Hospital Foch2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年2月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Simple endpoint: - Difference in visual recovery (difference between pre-operative and post-operative visual acuity) at 3 months post-operatively (after a successful reapplication procedure) (EDTRS scale) between the 2 groups (treatment and placebo)
研究概览
简要总结
To evaluate the efficacy of UDCA in the recovery of visual acuity at 3 months (i.e., the difference between pre-operative visual acuity and visual acuity 3 months after surgery), in pseudophakic or aphakic patients who have undergone successful surgery (retinal reapplication) by vitrectomy and gas tamponade following rhegmatogenous retinal detachment (RRD).
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment period
- 盲法
- Single (Monitor, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 or over
- •scheduled for vitrectomy surgery
- •Aphake or pseudophake patients,
- •With rhegmatogenous retinal detachment affecting 2 or more quadrants,
- •With rhegmatogenous retinal detachment affecting 2 or more quadrants,
- •Having signed a consent form,
- •Affiliated with a health insurance
排除标准
- •Patients who have previously undergone vitrectomy for retinal detachment,
- •Patients suffering from Crohn's disease, haemorrhagic rectocolitis or other intestinal diseases which may alter the enterohepatic circulation of bile acids
- •Patients undergoing oral treatment with cholestyramine, colestipol, antacids containing aluminium or magnesium hydroxide and/or smectite (aluminium oxide), ciclosporin, ciprofloxacin, nitrendipine or dapsone
- •Patients with galactose intolerance, Lapp lactate deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)
- •Patient taking part in or being excluded from interventional research and taking medicines prohibited in the context of this study
- •Patient placed under protective supervision
- •Patient with vitreous bleeding or any other associated retinal pathology
- •Monophthalmic patient
- •Women of childbearing age without an effective method of contraception
- •Pregnant or breast-feeding woman,
- •Hypersensitivity to the active substance, to bile acids or to one of the excipients of Ursolvan®
- •Patients suffering from peptic ulcer, acute or chronic liver disease, acute infection or inflammation of the gall bladder or bile ducts, repeated biliary colic, occlusion of the bile ducts (bile duct or cystic duct occlusion)
- •Patients with radiopaque calcified gallstones
- •Patient with severe pancreatic disease
结局指标
主要结局
Simple endpoint: - Difference in visual recovery (difference between pre-operative and post-operative visual acuity) at 3 months post-operatively (after a successful reapplication procedure) (EDTRS scale) between the 2 groups (treatment and placebo)
Simple endpoint: - Difference in visual recovery (difference between pre-operative and post-operative visual acuity) at 3 months post-operatively (after a successful reapplication procedure) (EDTRS scale) between the 2 groups (treatment and placebo)
次要结局
- CNE thickness, measured by SD-OCT, in the central 1 and 3 mm relative to the contralateral eye in the treatment group versus the placebo group (measurement adjusted relative to the contralateral eye to eliminate interindividual variability) at 1, 3 and 6 months.
- Automated microperimetry at 1, 3 and 6 months: difference in macular sensitivity between the 2 groups.
- Measuring contrast sensitivity on the Clinic CSF2.012 application
- Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, outer limiting membrane, etc.).
- Retinal thickness of different layers measured on OCT (retinal layers and presence of cysts segmentation of layers and measurement on central 1 and 3 mm in ETDRS quadrants).
- Number of macular cones and pigment epithelium cells (RPE) measured by Adaptive Optics at 1, 3 and 6 months with the Cellularis device, which visualizes cones and RPE 13
- Blood test: liver parameters: AST (SGOT), ALT (SGPT), PAL and γ -GT.
- Evolution of best visual acuity measured at D0, D7, D30, D60, D90 and D180: difference between treatment and placebo groups in visual acuity progression curves.
- Presence of metamorphospises.
- Tolerance and occurrence of adverse events
- National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) before surgery, at D±7 post-op and at 3 months post-op.
- Correlation between levels of proteins, bile acids or other molecular markers in ocular fluids and/or blood and pre- and post-operative functional and anatomical ocular parameters at different observation times.
- Correlation between effective treatment duration and functional and anatomical results at different observation times.
研究者
Pr. Francine BEHAR-COHEN
Scientific
Hospital Foch
研究点 (2)
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