Ursodeoxycholic acid for Rhegmatogenous retinal detachment

Inclusion criteria

• {"criterion_text":"- Patient aged 18 or over\n- scheduled for vitrectomy surgery\n- Aphake or pseudophake patients,\n- With rhegmatogenous retinal detachment affecting 2 or more quadrants,\n- With rhegmatogenous retinal detachment affecting 2 or more quadrants,\n- Having signed a consent form,\n- Affiliated with a health insurance"}

Exclusion criteria

• {"criterion_text":"- Patients who have previously undergone vitrectomy for retinal detachment,\n- Patients suffering from Crohn's disease, haemorrhagic rectocolitis or other intestinal diseases which may alter the enterohepatic circulation of bile acids\n- Patients undergoing oral treatment with cholestyramine, colestipol, antacids containing aluminium or magnesium hydroxide and/or smectite (aluminium oxide), ciclosporin, ciprofloxacin, nitrendipine or dapsone\n- Patients with galactose intolerance, Lapp lactate deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)\n- Patient taking part in or being excluded from interventional research and taking medicines prohibited in the context of this study\n- Patient placed under protective supervision\n- Patient with vitreous bleeding or any other associated retinal pathology\n- Monophthalmic patient\n- Women of childbearing age without an effective method of contraception\n- Pregnant or breast-feeding woman,\n- Hypersensitivity to the active substance, to bile acids or to one of the excipients of Ursolvan®\n- 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)\n- Patients with radiopaque calcified gallstones\n- Patient with severe pancreatic disease"}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Difference between pre-operative and post-operative visual acuity at 3 months post-operatively measured on the ETDRS (EDTRS) scale between treatment and placebo groups (after successful retinal reapplication)."}

Secondary endpoints

• {"endpoint_text":"- 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.\n- Automated microperimetry at 1, 3 and 6 months: difference in macular sensitivity between the 2 groups.\n- Measuring contrast sensitivity on the Clinic CSF2.012 application\n- Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, outer limiting membrane, etc.).\n- 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).\n- 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\n- Blood test: liver parameters: AST (SGOT), ALT (SGPT), PAL and γ -GT.\n- 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.\n- Presence of metamorphospises.\n- Tolerance and occurrence of adverse events\n- National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) before surgery, at D±7 post-op and at 3 months post-op.\n- 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.\n- Correlation between effective treatment duration and functional and anatomical results at different observation times.","definition_or_measurement_approach":"CNE thickness measured by SD-OCT (central 1 and 3 mm, adjusted to contralateral eye) at 1, 3, 6 months; Automated microperimetry for macular sensitivity at 1,3,6 months; Contrast sensitivity measured on Clinic CSF2.012 application; OCT used to assess presence/absence of abnormal signs and retinal layer thickness (segmentation, central 1 and 3 mm ETDRS quadrants); Adaptive Optics (Cellularis) to count macular cones and RPE at 1,3,6 months; Blood tests for liver parameters AST/ALT/PAL/γ-GT; Best-corrected visual acuity measured at D0, D7, D30, D60, D90, D180 and compared between groups; Assessment of metamorphopsia presence; Collection and reporting of adverse events; NEI VFQ-25 administered pre-op, around D7 post-op, and at 3 months; Correlative analyses between molecular marker levels in ocular fluids/blood and ocular functional/anatomical parameters; Correlation analyses between treatment duration and outcomes."}

France

Earliest CTIS Part Ii Submission Date

28-11-2023

Latest Decision Or Authorization Date

21-02-2024

Processing Time Days

85

Number Of Sites

2

Number Of Participants

120

Primary sponsor

Full Name

Hospital Foch

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"DRCI Hôpital Foch","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"CHEPLAPHARM ARZNEIMITTEL GMBH","duties_or_roles":"Marketing authorisation holder / manufacturer name associated with URSOLVAN product dictionary","organisation_type":""}
• {"country":"France","full_name":"Cooper (Melun, France)","duties_or_roles":"Supplier of raw materials / placebo capsule supplier","organisation_type":""}