Trial record 3 of 31 for:    Open Studies | "Retinal Detachment"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Hospital Inselspital, Berne
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT02068625
First received: February 19, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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 Intervention Phase
Retinal Detachment
Drug: Rasagiline
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • ETDRS Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Central retinal thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by Optical Coherence Tomography (OCT)

  • Number of patients with side effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068625

Contacts
Contact: Andreas Ebneter +41 (0)31 632 25 01 augenheilkunde@insel.ch
Contact: Corinne Stöckli +41 (0)31 632 25 01 augenheilkunde@insel.ch

Locations
Switzerland
Department of Ophthalmology, Bern University Hospital Recruiting
Bern, Switzerland, 3010
Principal Investigator: Andreas Ebneter         
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
  More Information

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02068625     History of Changes
Other Study ID Numbers: 178/10, 2012DR2022
Study First Received: February 19, 2014
Last Updated: February 19, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
retinal detachment
rasagiline
optical coherence tomography
visual acuity
neuroprotection
azilect

Additional relevant MeSH terms:
Retinal Detachment
Dissociative Disorders
Retinal Diseases
Eye Diseases
Mental Disorders
Rasagiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014