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UrsoDeoxyCholic Acid (UDCA) as neuroprotective treatment adjuvant to rhegmatogenous retinal detachment surgery
EU CTIS ID: 2023-505106-41-01
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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,
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.