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Study on the Use of Ursodeoxycholic Acid for Patients Undergoing Surgery for Retinal Detachment

Registered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of UrsoDeoxyCholic Acid (UDCA) as a supportive treatment for patients undergoing surgery for rhegmatogenous retinal detachment. This condition occurs when the retina, a layer at the back of the eye, detaches from its normal position, which can lead to vision loss if not treated promptly. The trial aims to assess whether UDCA can help improve vision recovery after surgery.

Participants in the study will receive either UDCA or a placebo. UDCA is administered in the form of a hard capsule called URSOLVAN 200 mg, which is taken orally. The study will monitor the recovery of visual acuity, which is the clarity or sharpness of vision, over a period of three months following the surgery. The goal is to determine if there is a significant improvement in vision for those taking UDCA compared to those who receive the placebo.

Throughout the study, various aspects of eye health will be evaluated, including the thickness of the retina and the sensitivity of the macula, which is the central part of the retina responsible for detailed vision. The study will also track any side effects or adverse events experienced by participants. The findings from this trial could provide valuable insights into the potential benefits of UDCA as a neuroprotective treatment in eye surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age (18 or over), scheduled vitrectomy surgery, and specific eye conditions.
Consent is required, and health insurance affiliation is necessary.
Step 2
Pre-operative assessment
Visual acuity is measured before surgery to establish a baseline for later comparison.
Additional tests may include blood tests to check liver parameters and other assessments to evaluate eye health.
Step 3
Surgery
The surgery involves vitrectomy and gas tamponade to address rhegmatogenous retinal detachment.
This procedure is essential for the study's main objective of evaluating visual recovery.
Step 4
Medication administration
After surgery, the medication ursodeoxycholic acid is administered.
The dosage is 200 mg, taken orally in the form of hard capsules.
Two capsules are taken daily with water, either with meals or independently, for a duration of four weeks.
Step 5
Post-operative assessments
Visual acuity is measured at various intervals: immediately after surgery, at 7 days, 30 days, 60 days, 90 days, and 180 days.
Additional tests include measuring retinal thickness, macular sensitivity, and contrast sensitivity.
The presence of any abnormal signs in the eye is monitored using optical coherence tomography (OCT).
Step 6
Follow-up and evaluation
The study aims to evaluate the difference in visual recovery between the treatment and placebo groups over a period of three months.
Secondary evaluations include the thickness of the retina, macular sensitivity, and other eye health indicators.
The study is expected to conclude by July 2027, with ongoing assessments to ensure comprehensive data collection.

Who can join the trial?

6 criteria

Patient aged 18 or over
Scheduled for vitrectomy surgery (a type of eye surgery)
Aphake or pseudophake patients (patients who have had cataract surgery and either do not have a lens or have an artificial lens)
With rhegmatogenous retinal detachment affecting 2 or more quadrants (a condition where the retina detaches from the back of the eye)
Having signed a consent form
Affiliated with a health insurance

Who cannot join the trial?

5 criteria

Patients who have not had successful surgery for their eye condition.
Patients who have not undergone a specific type of eye surgery called vitrectomy with gas tamponade. A vitrectomy is a surgery to remove the gel-like substance inside the eye, and gas tamponade is a technique used to help the retina heal.
Patients who are not pseudophakic or aphakic. Pseudophakic means having an artificial lens in the eye after cataract surgery, and aphakic means not having a lens in the eye.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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Investigated drugs

UrsoDeoxyCholic Acid (UDCA) is being studied as a potential neuroprotective treatment. It is used in this trial as an additional therapy to support the recovery of visual acuity after surgery for retinal detachment. The goal is to see if UDCA can help improve vision in patients who have had successful retinal reattachment surgery.

Ursodeoxycholic Acid

What is already known about the treatment

UrsoDeoxyCholic Acid (UDCA) – This medication is administered orally and is currently being studied as a neuroprotective treatment to support surgery for rhegmatogenous retinal detachment. It is in the clinical trial phase, with ongoing research to determine its effectiveness in improving visual acuity post-surgery. UDCA is primarily indicated for patients who have undergone successful retinal reattachment surgery. At the molecular level, UDCA works by reducing oxidative stress and inflammation, which may help protect nerve cells in the retina. It is classified as a bile acid, traditionally used for liver-related conditions, but now being explored for its potential benefits in eye health.

Investigated diseases

Rhegmatogenous Retinal Detachment – This condition occurs when a tear or break in the retina allows fluid to get under the retina, causing it to detach from the underlying tissue. It often begins with symptoms like sudden flashes of light, floaters, or a shadow over part of the visual field. As the detachment progresses, the area of vision loss can increase, potentially leading to significant vision impairment if not addressed. The detachment typically starts in the peripheral retina and can spread towards the central retina, affecting central vision. It is most commonly seen in individuals who are middle-aged or older, and those who are nearsighted or have had eye surgery or trauma. Early detection and surgical intervention are crucial to prevent permanent vision loss.