UrsoDeoxyCholic Acid (UDCA) as neuroprotective treatment adjuvant to rhegmatogenous retinal detachment surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Foch

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

20 Aug 2024 → ongoing

Decision date (initial)

2024-02-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DRCI Hôpital Foch

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the efficacy of UDCA in the recovery of visual acuity at 3 months (i.e., the difference between pre-operative visual acuity and visual acuity 3 months after surgery), in pseudophakic or aphakic patients who have undergone successful surgery (retinal reapplication) by vitrectomy and gas tamponade following rhegmatogenous retinal detachment (RRD).

Secondary objectives 3

1. To analyse the other criteria of efficacy of treatment (anatomical and functional)
2. To analyze the ocular and systemic tolerability of UDCA in patients with RRD.
3. Correlate blood and/or ocular biological parameters with ocular anatomical and functional parameters.

Conditions and MedDRA coding

rhegmatogenous retinal detachment

Study design 1 period

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patient aged 18 or over
2. scheduled for vitrectomy surgery
3. Aphake or pseudophake patients,
4. With rhegmatogenous retinal detachment affecting 2 or more quadrants,
5. With rhegmatogenous retinal detachment affecting 2 or more quadrants,
6. Having signed a consent form,
7. Affiliated with a health insurance

Exclusion criteria 14

1. Patients who have previously undergone vitrectomy for retinal detachment,
2. Patient with vitreous bleeding or any other associated retinal pathology
3. Monophthalmic patient
4. Women of childbearing age without an effective method of contraception
5. Pregnant or breast-feeding woman,
6. Hypersensitivity to the active substance, to bile acids or to one of the excipients of Ursolvan®
7. Patients suffering from peptic ulcer, acute or chronic liver disease, acute infection or inflammation of the gall bladder or bile ducts, repeated biliary colic, occlusion of the bile ducts (bile duct or cystic duct occlusion)
8. Patients with radiopaque calcified gallstones
9. Patient with severe pancreatic disease
10. Patients suffering from Crohn's disease, haemorrhagic rectocolitis or other intestinal diseases which may alter the enterohepatic circulation of bile acids
11. Patients undergoing oral treatment with cholestyramine, colestipol, antacids containing aluminium or magnesium hydroxide and/or smectite (aluminium oxide), ciclosporin, ciprofloxacin, nitrendipine or dapsone
12. Patients with galactose intolerance, Lapp lactate deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases)
13. Patient taking part in or being excluded from interventional research and taking medicines prohibited in the context of this study
14. Patient placed under protective supervision

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Simple endpoint: - Difference in visual recovery (difference between pre-operative and post-operative visual acuity) at 3 months post-operatively (after a successful reapplication procedure) (EDTRS scale) between the 2 groups (treatment and placebo)

Secondary endpoints 13

1. CNE thickness, measured by SD-OCT, in the central 1 and 3 mm relative to the contralateral eye in the treatment group versus the placebo group (measurement adjusted relative to the contralateral eye to eliminate interindividual variability) at 1, 3 and 6 months.
2. Automated microperimetry at 1, 3 and 6 months: difference in macular sensitivity between the 2 groups.
3. Measuring contrast sensitivity on the Clinic CSF2.012 application
4. Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, outer limiting membrane, etc.).
5. Retinal thickness of different layers measured on OCT (retinal layers and presence of cysts segmentation of layers and measurement on central 1 and 3 mm in ETDRS quadrants).
6. Number of macular cones and pigment epithelium cells (RPE) measured by Adaptive Optics at 1, 3 and 6 months with the Cellularis device, which visualizes cones and RPE 13
7. Blood test: liver parameters: AST (SGOT), ALT (SGPT), PAL and γ -GT.
8. Evolution of best visual acuity measured at D0, D7, D30, D60, D90 and D180: difference between treatment and placebo groups in visual acuity progression curves.
9. Presence of metamorphospises.
10. Tolerance and occurrence of adverse events
11. National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) before surgery, at D±7 post-op and at 3 months post-op.
12. Correlation between levels of proteins, bile acids or other molecular markers in ocular fluids and/or blood and pre- and post-operative functional and anatomical ocular parameters at different observation times.
13. Correlation between effective treatment duration and functional and anatomical results at different observation times.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Foch

Sponsor organisation

Hospital Foch

Address

40 Rue Worth

City

Suresnes

Postcode

92150

Country

France

Scientific contact point

Organisation

Hospital Foch

Contact name

Pr. Francine BEHAR-COHEN

Public contact point

Organisation

Hospital Foch

Contact name

Pr. Francine BEHAR-COHEN

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications