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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHopital Foch

About this trial

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 criteria

Qualifiers

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,

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • Ursolvan
  • Placebo

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators