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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

Tracking Information
First Submitted Date  ICMJE February 19, 2014
First Posted Date  ICMJE February 21, 2014
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE September 2010
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
ETDRS Visual Acuity [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
  • Central retinal thickness [ Time Frame: 6 months ]
    Measured by Optical Coherence Tomography (OCT)
  • Number of patients with side effects [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment
Official Title  ICMJE Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Retinal Detachment
Intervention  ICMJE
  • Drug: Rasagiline
    Rasagiline 1mg daily orally for 7 days
  • Drug: Placebo
    Oral treatment with placebo for 7 days
Study Arms  ICMJE
  • Experimental: Treatment
    Patients getting perioperative oral treatment with rasagiline (1mg daily) for 7 days
    Intervention: Drug: Rasagiline
  • Placebo Comparator: Control
    Patients getting perioperative oral treatment with placebo for 7 days
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 28, 2018)
23
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2014)
40
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02068625
Other Study ID Numbers  ICMJE 178/10
2012DR2022 ( Other Identifier: Swissmedic )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sebastian Wolf Department of Ophthalmology, Bern University Hospital
Principal Investigator: Andreas Ebneter Department of Ophthalmology, Bern University Hospital
PRS Account University Hospital Inselspital, Berne
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP