Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment|
- ETDRS Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Central retinal thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]Measured by Optical Coherence Tomography (OCT)
- Number of patients with side effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Patients getting perioperative oral treatment with rasagiline (1mg daily) for 7 days
Rasagiline 1mg daily orally for 7 days
Placebo Comparator: Control
Patients getting perioperative oral treatment with placebo for 7 days
Oral treatment with placebo for 7 days
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02068625
|Contact: Andreas Ebneter||+41 (0)31 632 25 firstname.lastname@example.org|
|Contact: Corinne Stöckli||+41 (0)31 632 25 email@example.com|
|Department of Ophthalmology, Bern University Hospital||Recruiting|
|Bern, Switzerland, 3010|
|Principal Investigator: Andreas Ebneter|
|Study Chair:||Sebastian Wolf||Department of Ophthalmology, Bern University Hospital|
|Principal Investigator:||Andreas Ebneter||Department of Ophthalmology, Bern University Hospital|