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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fraser Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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