Retinal Detachment
Conditions
Keywords
retinal detachment, rasagiline, optical coherence tomography, visual acuity, neuroprotection, azilect
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 description
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.
Interventions
DRUGRasagiline
Rasagiline 1mg daily orally for 7 days
DRUGPlacebo
Oral treatment with placebo for 7 days
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ETDRS Visual Acuity | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central retinal thickness | 6 months | Measured by Optical Coherence Tomography (OCT) |
| Number of patients with side effects | 6 months | — |
Countries
Switzerland
Outcome results
None listed