A Phase 3 interventional study of Ursolvan and Placebo in Retinal Detachment, sponsored by Hopital Foch. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Hopital Foch · Phase 3, Interventional, and Treatment
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:
199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 132 interventional studies indexed under Retinal Detachment.
Browse Retinal Detachment studies →Hopital Foch is the lead sponsor of 215 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Ursolvan
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.
Drug: Placebo
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.
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
Difference in visual recovery (difference between preoperative and postoperative visual acuity) at 3 months postoperative (after a successful reapplication procedure) of at least 6 letters (ETDRS scale) between the two groups (treatment and placebo)
Difference in visual recovery (difference between preoperative and postoperative visual acuity) at 3 months postoperative (after a successful reapplication procedure) of at least 6 letters (Early Treatment Diabetic Retinopathy Study (ETDRS scale) between the two groups (treatment and placebo). The minimum and maximums valus : Minimum value is 6/95 equivalent in ETDRS letter score read at 4 m = 55. Maximum value is 6/6 equivalement in ETDRS letter score read at 4 m= 115. Higher score mean better ourcome
Time frame: 3 months
Central Nervous Epithelium (CNE) thickness
Central Nervous Epithelium (CNE) thickness, measured by SD-OCT (Spectral-Domain Optical Coherence Tomography), within the central 1mm compared to the contralateral eye in the treated group versus the placebo group (measurement adjusted to the contralateral eye to account for interindividual variability) at 1, 3, and 6 months.
Time frame: 1, 3, and 6 months
Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups.
Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups.
Time frame: 1, 3, and 6 months
Contrast sensitivity measurement using the Clinic CSF2.0 application.
Contrast sensitivity measurement using the Clinic CSF2.012 application (Contrast sensitivity function 2.0 application).
Time frame: Day 7, Day 30, Day 60, Day 60, Day 90 and Day 180
Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, external limiting membrane).
Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, external limiting membrane).
Time frame: 1, 3 and 6 months
Retinal thickness measured by OCT (retinal layers and presence of cysts, layer segmentation and measurement in the central 1 and 3 mm in ETDRS quadrants).
Retinal thickness measured by OCT (retinal layers and presence of cysts, layer segmentation and measurement in the central 1 and 3 mm in ETDRS quadrants).
Time frame: 1, 3 and 6 months
Number of macular cones and retinal pigment epithelium (RPE) cells measured by Adaptive Optics at 1, 3, and 6 months with the "Cellularis" device that allows visualization of cones and RPE.
Number of macular cones and retinal pigment epithelium (RPE) cells measured by Adaptive Optics at 1, 3, and 6 months with the "Cellularis" device that allows visualization of cones and RPE.
Time frame: 1, 3 and 6 months
Blood test: liver parameters - AST (SGOT), ALT (SGPT), PAL, and γ-GT.
Blood test: liver parameters - AST (SGOT), ALT (SGPT), PAL, and γ-GT.
Time frame: Day 7 and Day 30
Evolution of the best visual acuity measured at Day 0, Day 7, Day 30, Day 60, Day 90, and Day 180: Difference between the treated and placebo groups in the progression curves of visual acuity.
Evolution of the best visual acuity measured at Day 0, Day 7, Day 30, Day 60, Day 90, and Day 180: Difference between the treated and placebo groups in the progression curves of visual acuity.
Time frame: Day 7 and Day 30
Presence of metamorphopsia.
Presence of metamorphopsia.
Time frame: 1, 3 and 6 months
Tolerance and occurrence of adverse events.
Tolerance and occurrence of adverse events.
Time frame: 1, 3 and 6 months
National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) quality of life questionnaire before surgery, at ±7 days postoperative, and at 3 months postoperative.
National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) quality of life questionnaire before surgery, at ±7 days postoperative, and at 3 months postoperative.
Time frame: 1, 3 and 6 months
Correlation between protein levels, bile acids, or other molecular markers in ocular and/or blood fluids and functional and anatomical ocular parameters pre- and post-operatively at different observation times.
Correlation between protein levels, bile acids, or other molecular markers in ocular and/or blood fluids and functional and anatomical ocular parameters pre- and post-operatively at different observation times.
Time frame: 1 month
Correlation between the effective duration of treatment and functional and anatomical outcomes at different observation times.
Correlation between the effective duration of treatment and functional and anatomical outcomes at different observation times.
Time frame: 6 months
Started Aug 2024 (actual). Primary completion is estimated for May 2027, 33 months after the start.
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Studies of the drug tested here: Ursodeoxycholic Acid