Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5%

May 22, 2015 updated by: Fraser Health

Can Urgent Reduction of Intraocular Pressure With Ophthalmic Timolol Improve Recovery From Non-arteritic Anterior Ischemic Optic Neuropathy (NAION): a Randomized Study.

The purpose of this study is to evaluate the feasibility of rapid evaluation and administration of ophthalmic Timolol maleate in the treatment of non-arteritic anterior ischemic optic neuropathy. Secondary goals are to evaluate if such treatment reduces the progression or improves recovery of patients who are randomly assigned to treatment versus standard of care.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Non-arteritic anterior ischemic optic neuropathy (NAION) currently has no widely accepted acute treatment to improve recovery or prevent progression in the first month. It causes monocular vision loss with potential second eye involvement in 15% at 5 years. This leads to significant disability. It is the most common acute optic neuropathy in patients over 55 years of age. The final mechanism of injury is believed to be ischemic. Increasing perfusion of the optic nerve may reduce damage and prevent progression. Reduction in intraocular pressure has been shown to increase optic disc perfusion in animal models. Timolol maleate is a widely used medication for Glaucoma that reduces intraocular pressure. Treatment with Timolol maleate may improve optic disc perfusion in NAION and reduce ischemic damage from this condition. This study aims to enroll and treat patients with Timolol maleate 0.5% within 48 hours of symptom onset to assess feasibility of the study design and potential benefit of rapid intraocular pressure reduction.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3T 0G9
        • Jim Pattison Outpatient Care and Surgery Centre, 3C Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >40
  • Sudden, painless monocular vision loss with edema of the optic disc
  • Clinical diagnosis is Non-Arteritic Anterior Ischemic Optic Neuropathy
  • Relative Afferent Pupil Defect (RAPD) at first study visit

Exclusion Criteria:

  • Onset of vision loss >48 hours from time of enrollment
  • History of Asthma or COPD
  • History of Heart Block or Sinus Bradycardia
  • Allergy to any beta blocker
  • History of Multiple Sclerosis or optic neuropathy
  • Active Ocular Inflammation on examination
  • Currently being treated for Cancer or systemic vasculitis
  • History of Glaucoma or use of medications that lower IOP
  • Symptomatic cataract, retinopathy, macular disease or amblyopia in the symptomatic eye
  • IOP of <10 at baseline
  • Ocular surgery in past three months
  • Women who are pregnant, breast-feeding or may become pregnant
  • Inability to provide informed consent or follow up at three months
  • Currently enrolled in any other study drug trial or previously enrolled in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Timolol
This group will receive ophthalmic Timolol maleate 0.5%, 1 drop to the effected eye twice daily for 4 weeks.
Drug: Timolol maleate
Timolol 0.5% 1 drop twice daily to the effected eye for 4 weeks.
Other Names:
  • Timoptic.
  • Timolol.
  • Timolol maleate.
No Intervention: Standard Care
This group will be treated with current standard care. This does not include Timolol or other medications to reduce intraocular pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate of patients during the one year study to assess feasibility of a larger study
Time Frame: 12 months
This is to define the feasabilty of the study design for a larger study.
12 months
Number of patients with adverse events
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual acuity at enrollment and three month follow up using a logMAR scale.
Time Frame: Enrolment, Within 48 hours of enrollment , 1 month, 3 months.
This will evaluate the change in visual acuity as a measure of visual function.
Enrolment, Within 48 hours of enrollment , 1 month, 3 months.
Change in the mean deviation of actual versus predicted sensitivity of the visual field.
Time Frame: 48 hours after enrollment, 1 month, 3 months
Using a a Haag-Streit Octopus 900 with white on white TOP 30-2 visual field program, the mean deviation will be compared at various time points to assess for improving visual function as it relates to the field of vision.
48 hours after enrollment, 1 month, 3 months
Change in Colour vision as measured by HRR colour plates.
Time Frame: Within 48 hours of enrollment, 1 month, 3 months
The total number of colour plates seen will be counted and compared to baseline as a measure of visual recovery as it effects colour vision.
Within 48 hours of enrollment, 1 month, 3 months
Change in contrast sensitivity will be measured using the Pelli-Robson contrast sensitivity chart.
Time Frame: 48 hours from enrollment, 1 month, 3 months.
The Pelli-Robson contrast sensitivity chart is another method to assess visual function. The change in total number of plates seen will be compared at the various time points.
48 hours from enrollment, 1 month, 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fraser Health

Investigators

  • Principal Investigator: Martin A SuttonBrown, MD, Fraser Health Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

May 25, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (Estimate)

May 30, 2012

Study Record Updates

Last Update Posted (Estimate)

May 25, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAION-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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