Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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). 120 patients will be enrolled and randomized in two groups: * the experimental arm UDCA Group, with oral administration of ursodeoxycholic acid (Ursolvan®) * the control group Placebo Group, with oral administration of the placebo.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hôpital Cochin
RECRUITING
Paris
Hôpital Foch
RECRUITING
Suresnes
Contact Information
Primary
BEHAR COHEN Francine
f.behar-cohen@hopital-foch.com
0146252275
Time Frame
Start Date: 2024-08-20
Estimated Completion Date: 2027-11
Participants
Target number of participants: 120
Treatments
Experimental: Experimental arm: 'UDCA'
Experimental arm: 'UDCA': Patients will be treated with ursodeoxycholic acid (UDCA), receiving a single dose of Ursolvan® (10mg/kg) orally within 24 hours before the surgical intervention, followed by a daily dose of 10mg/kg in two divided doses for 30 days.
Placebo_comparator: Control arm: 'Placebo'
Control arm: 'Placebo': Patients will receive a single dose of placebo orally within 24 hours before the surgical intervention, followed by two doses per day for 30 days.
Related Therapeutic Areas
Sponsors
Leads: Hopital Foch

This content was sourced from clinicaltrials.gov