Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment

Study Overview
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Brief Summary
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This randomised, double-blind, placebo-controlled clinical trial investigates the neuroprotective effect of rasagiline in patients suffering from a retinal detachment affecting central vision. Based on results from a study in mice suffering from retinal degeneration, the investigators hypothesize that rasagiline delays neurodegeneration in the retina and improves visual acuity outcomes after retinal detachment surgery. Rasagiline is a second-generation propargylamine with neuroprotective properties modulating the caspase-dependent pathway of programmed cell death.

Detailed Description
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Background In previous experimental studies neuroprotection by rasagiline has been shown in rds-mice, a model for slow retinal degeneration. It is known from these experiments that rasagiline specifically delays apoptosis, but also modifies inflammation and autophagy. The bioavailability of the drug in the central nervous system is high, and based on the literature is sufficient in the retina. In retinal detachments the outer layers of the neurosensory retina are deprived of nutrients and degeneration of the photoreceptors occurs fast. This is particularly relevant in the macular area of the retina where the density of photoreceptors is high, such that visual acuity recovery can be significantly limited by photoreceptor loss. Objective To assess the neuroprotective effect of oral rasagiline (1mg daily for 7 days) administered perioperatively in patients undergoing surgical retinal detachment repair for central vision involving retinal detachments. Methods In this clinical trial, patients suffering from retinal detachments affecting the fovea get randomly assigned to perioperative oral treatment with either rasagiline (1mg) or placebo once daily for 7 days. Pharmacologic treatment is initiated at the time of hospital admission, usually the day before surgery. The main outcome of the study is visual acuity six months after surgical retinal detachment repair. Structural differences of the neurosensory retina between groups will be analysed by optical coherence tomography, a non-invasive imaging method for retinal pathology.

Official Title
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Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment

Conditions
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Retinal Detachment

Intervention / Treatment
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* Drug: Rasagiline
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rhegmatogenous retinal detachment Central vision affected for less than 72 hours Pseudophakic Age 18 or over Not participating in other clinical trials Willing to attend follow-up visits Written informed consent Exclusion Criteria Phakic Narrow angle glaucoma Previous intraocular surgery other than cataract operation Retinal disease Concurrent treatment with MAO inhibitors Pregnancy Malignant arterial hypertension Liver or kidney failure Life-threatening or malignant disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients getting perioperative oral treatment with rasagiline (1mg daily) for 7 days | Drug: Rasagiline<br>* Rasagiline 1mg daily orally for 7 days<br>|
| Placebo Comparator: Control<br>Patients getting perioperative oral treatment with placebo for 7 days | Drug: Placebo<br>* Oral treatment with placebo for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ETDRS Visual Acuity |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central retinal thickness | Measured by Optical Coherence Tomography (OCT) | 6 months | 
| Number of patients with side effects |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal detachment, rasagiline, optical coherence tomography, visual acuity, neuroprotection, azilect