Retinal DetachmentPhase 3UDCANCT06294847
Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery
A Phase 3 study testing Ursolvan in people with Retinal Detachment, run by Hopital Foch at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Ursolvan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Aug 2024to Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
- Pregnant or lactating women,
- Hypersensitivity to the active substance, bile acids, or any of the excipients in Ursolvan® (see §6.1.1 of this protocol),
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- Patients with peptic ulcers, acute or chronic liver disease, acute infection or inflammation of the gallbladder or bile ducts, recurrent gallstones, or obstruction of the bile ducts (common bile duct or cystic duct obstruction),
- Patients with radiopaque calcified gallstones,
- Patients with severe pancreatic disorders,
- Patients with Crohn's disease, ulcerative colitis, or other intestinal diseases that may alter the enterohepatic circulation of bile acids,
- Patients on oral treatment with cholestyramine, colestipol, antacids containing aluminum or magnesium hydroxide and/or smectite (aluminum oxide), cyclosporine, ciprofloxacin, nitrendipine, or dapsone,
- Patients with galactose intolerance, Lapp lactase deficiency, or glucose and galactose malabsorption syndrome (rare hereditary diseases),
- Patients participating or in the exclusion period following an interventional research with the use of prohibited medications in this study,
- Patients under protective custody.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Cochin
Paris, 75014
EYMARD Pauline, Dr, pauline.eymard@aphp.fr
EYMARD Pauline
- Recruiting
Hôpital Foch
Suresnes, 92150
Behar Cohen Francine, Pr, 01 46 25 22 75, .behar-cohen@hopital-foch.com
Behar Cohen Francine, Pr
About this study
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).
Read more
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.
- Conditions
- Retinal Detachment
- Being tested
- Ursolvan, Placebo
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrsolvanDrug
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.
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ursolvan |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 7 and Day 30
Presence of metamorphopsia.
Presence of metamorphopsia.
Measured: 1, 3 and 6 months
Tolerance and occurrence of adverse events.
Tolerance and occurrence of adverse events.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start20 Aug 2024
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294847
- Sponsor's protocol ID
- 2021_0025
- Acronym
- UDCA
- Status last verified
- May 2025
- First submitted
- 28 Feb 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery
- ClinicalTrials.gov ID
- NCT06294847
- Acronym / sponsor ID
- UDCA / 2021_0025
- Conditions
- Retinal Detachment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm: 'UDCA' | Experimental | Drug: UrsolvanExperimental 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. |
| Control arm: 'Placebo' | Placebo comparator | Drug: PlaceboControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (14 listed)
- 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,
- Pregnant or lactating women,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursolvansingle 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 | Experimental arm: 'UDCA' |
| PlaceboPatients 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 | Control arm: 'Placebo' |
Primary outcome
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)
Time frame: 3 months
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
13 secondary outcomes
Central Nervous Epithelium (CNE) thickness
Time frame: 1, 3, and 6 months
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.
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).
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).
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.
Time frame: 1, 3 and 6 months
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.
Time frame: Day 7 and Day 30
Presence of metamorphopsia.
Time frame: 1, 3 and 6 months
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.
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.
Time frame: 1 month
Correlation between the effective duration of treatment and functional and anatomical outcomes at different observation times.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ursolvan in people with Retinal Detachment, run by Hopital Foch at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BEHAR COHEN Francine (0146252275 ext. +33, f.behar-cohen@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.