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

Phase 4

Terminated

• Conditions: Retinal Detachment
• Interventions: Drug: Placebo; Drug: Rasagiline

• Registration Number: NCT02068625
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-21
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Patients getting perioperative oral treatment with placebo for 7 days
Treatment	Rasagiline	Patients getting perioperative oral treatment with rasagiline (1mg daily) for 7 days

Primary Outcome Measures

Name	Time	Method
ETDRS Visual Acuity	6 months

Secondary Outcome Measures

Name	Time	Method
Number of patients with side effects	6 months
Central retinal thickness	6 months	Measured by Optical Coherence Tomography (OCT)

Trial Locations

Locations (1)

Department of Ophthalmology, Bern University Hospital; 🇨🇭 Bern, Switzerland