Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02068625|
Recruitment Status : Terminated (Persisting recruitment difficulties)
First Posted : February 21, 2014
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Retinal Detachment||Drug: Rasagiline Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment|
|Actual Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
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
- ETDRS Visual Acuity [ Time Frame: 6 months ]
- Central retinal thickness [ Time Frame: 6 months ]Measured by Optical Coherence Tomography (OCT)
- Number of patients with side effects [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068625
|Department of Ophthalmology, Bern University Hospital|
|Bern, Switzerland, 3010|
|Study Chair:||Sebastian Wolf||Department of Ophthalmology, Bern University Hospital|
|Principal Investigator:||Andreas Ebneter||Department of Ophthalmology, Bern University Hospital|