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

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Terminated

CT.gov ID

NCT02068625

Collaborator

(none)

Enrollment

Location

Arms

100

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment	Drug: Rasagiline Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

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 :

Sep 1, 2010

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Patients getting perioperative oral treatment with rasagiline (1mg daily) for 7 days	Drug: Rasagiline Rasagiline 1mg daily orally for 7 days
Placebo Comparator: Control Patients getting perioperative oral treatment with placebo for 7 days	Drug: Placebo Oral treatment with placebo for 7 days

Arm

Intervention/Treatment

Experimental: Treatment

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

Drug: Rasagiline

Rasagiline 1mg daily orally for 7 days

Placebo Comparator: Control

Patients getting perioperative oral treatment with placebo for 7 days

Drug: Placebo

Oral treatment with placebo for 7 days

Outcome Measures

Primary Outcome Measures

ETDRS Visual Acuity [6 months]

Secondary Outcome Measures

Central retinal thickness [6 months]
Measured by Optical Coherence Tomography (OCT)
Number of patients with side effects [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology, Bern University Hospital	Bern		Switzerland	3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Study Chair: Sebastian Wolf, Department of Ophthalmology, Bern University Hospital
Principal Investigator: Andreas Ebneter, Department of Ophthalmology, Bern University Hospital