Clinical Trial: Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment
Brief Summary: 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 Summary:
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.
Sponsor: University Hospital Inselspital, Berne
Current Primary Outcome: ETDRS Visual Acuity [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Central retinal thickness [ Time Frame: 6 months ]Measured by Optical Coherence Tomography (OCT)
- Number of patients with side effects [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: University Hospital Inselspital, Berne
Dates:
Date Received: February 19, 2014
Date Started: September 2010
Date Completion: December 2020
Last Updated: January 30, 2017
Last Verified: January 2017
