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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
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2010
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. ETDRS Visual Acuity [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Central retinal thickness [ Time Frame: 6 months ]
    Measured by Optical Coherence Tomography (OCT)

  2. Number of patients with side effects [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Switzerland
Department of Ophthalmology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Chair: Sebastian Wolf Department of Ophthalmology, Bern University Hospital
Principal Investigator: Andreas Ebneter Department of Ophthalmology, Bern University Hospital
Publications:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02068625    
Other Study ID Numbers: 178/10
2012DR2022 ( Other Identifier: Swissmedic )
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Keywords provided by University Hospital Inselspital, Berne:
retinal detachment
rasagiline
optical coherence tomography
visual acuity
neuroprotection
azilect
Additional relevant MeSH terms:
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Retinal Detachment
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs