Actively Recruiting
Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery
Led by Hopital Foch · Updated on 2025-05-14
120
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of ursodeoxycholic acid (UDCA) as a supportive treatment to improve visual recovery after surgery for extended rhegmatogenous retinal detachment (RRD) involving two or more quadrants, with macula off for seven days or less. The study focuses on pseudophakic or aphakic patients who are scheduled for vitrectomy and gas tamponade surgery. The goal is to compare visual acuity improvements three months after surgery between patients receiving UDCA and those receiving a placebo. The trial enrolls 120 patients randomized into two groups. The experimental group receives oral UDCA, starting with a single dose of 10 mg/kg within 24 hours before surgery, then continuing with 10 mg/kg daily in two doses for 30 days. The control group receives a matching placebo on the same schedule. Both treatments are given alongside the standard surgical procedure involving vitrectomy and gas tamponade. Participants will be followed for six months with multiple assessments, including visual acuity tests at various timepoints up to 180 days, imaging such as optical coherence tomography (OCT), automated microperimetry, and adaptive optics to examine retinal cells. Blood tests monitor liver function, and questionnaires evaluate vision-related quality of life. Researchers will track adverse events and analyze correlations between molecular markers and ocular outcomes to assess the treatment's impact and safety.
CONDITIONS
Brief Title
Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Scheduled for vitrectomy surgery
- Pseudophakic or aphakic patients
- Rhegmatogenous retinal detachment involving 2 or more quadrants
- Macula off for 7 days or less before symptoms started
- Signed informed consent
- Affiliated with a health insurance plan
You will not qualify if you...
- Previous vitrectomy surgery for retinal detachment
- Presence of vitreous hemorrhage or other retinal diseases
- Monophthalmic patients (only one eye)
- Women of childbearing age without effective contraception
- Pregnant or breastfeeding women
- Hypersensitivity to UDCA or its components
- Peptic ulcers or liver diseases
- Infections or inflammation of gallbladder or bile ducts
- Gallstones or obstruction of bile ducts
- Severe pancreatic disorders
- Intestinal diseases affecting bile acid circulation
- Use of certain interacting medications
- Rare hereditary metabolic diseases
- Participation in other interventional trials with prohibited drugs
- Patients under protective custody
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants undergo retinal detachment surgery and receive a single dose of study medication or placebo orally within 24 hours before the surgical intervention.
1 visit (in-person)
Duration - 30 days
Participants take daily doses of the study medication or placebo orally in two divided doses for 30 days following surgery.
Visits on Day 7 and Day 30 (in-person)
Duration - 6 months
Participants are monitored with assessments of visual acuity, retinal imaging, and quality of life questionnaires up to 6 months after surgery.
Multiple visits at 1, 3, and 6 months post-surgery
Trial Site Locations
Total: 2 locations
1
Hôpital Cochin
Paris, France, 75014
Actively Recruiting
2
Hôpital Foch
Suresnes, France, 92150
Actively Recruiting
Research Team
B
BEHAR COHEN Francine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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