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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm: 'UDCA' | Experimental | 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. |
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| Control arm: 'Placebo' | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursolvan | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1, 3, and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BEHAR COHEN Francine | Contact | 0146252275 | +33 | f.behar-cohen@hopital-foch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin | Recruiting | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| Placebo | Drug | 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 |
|
| 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. | 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). | 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). | 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). | 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. | 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. | 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. | Day 7 and Day 30 |
| Presence of metamorphopsia. | Presence of metamorphopsia. | 1, 3 and 6 months |
| Tolerance and occurrence of adverse events. | Tolerance and occurrence of adverse events. | 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. | 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. | 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. | 6 months |
| Hôpital Foch | Recruiting | Suresnes | 92150 | France |
|
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |