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New treatment option for Retinal Detachment
Official title Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery
ClinicalTrials.gov ID: NCT06294847
What this study is testing
What is Ursolvan?
Ursolvan is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for retinal detachment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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,
You likely can't join if
- 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),
See the full eligibility 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.
- 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...
- 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 treatment research with the use of prohibited medications in this study,
- Patients under protective custody.
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Suresnes, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Suresnes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.