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

Insel Gruppe AG, University Hospital Bern

Status and phase: Terminated; Phase 4

Conditions: Retinal Detachment

Treatments: Drug: Placebo; Drug: Rasagiline

Study type: Interventional

Funder types: Other

Identifiers

NCT02068625

2012DR2022 (Other Identifier)

178/10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Patients getting perioperative oral treatment with rasagiline (1mg daily) for 7 days

Treatment:

Drug: Rasagiline

Control

Placebo Comparator group

Description:

Patients getting perioperative oral treatment with placebo for 7 days

Treatment:

Drug: Placebo