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

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. Identifier: NCT01607671
Recruitment Status : Withdrawn (Unable to recruit participants from recruiting sites.)
First Posted : May 30, 2012
Last Update Posted : May 25, 2015
Information provided by (Responsible Party):
Fraser Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Optic Neuropathy, Ischemic Anterior Ischemic Optic Neuropathy Ischemic Optic Neuropathy Optic Neuropathy, Anterior Ischemic Drug: Timolol maleate Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Urgent Reduction of Intraocular Pressure With Ophthalmic Timolol Improve Recovery From Non-arteritic Anterior Ischemic Optic Neuropathy (NAION): a Randomized Study.
Study Start Date : June 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

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.

Primary Outcome Measures :
  1. 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.

  2. Number of patients with adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01607671

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Canada, British Columbia
Jim Pattison Outpatient Care and Surgery Centre, 3C Neurology
Surrey, British Columbia, Canada, V3T 0G9
Sponsors and Collaborators
Fraser Health
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Principal Investigator: Martin A SuttonBrown, MD Fraser Health Region
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Responsible Party: Fraser Health Identifier: NCT01607671    
Other Study ID Numbers: NAION-001
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 2012
Keywords provided by Fraser Health:
Optic Neuropathy
Non-Arteritic Anterior Ischemic Optic Neuropathy
Ischemic Optic Neuropathy
Intraocular Pressure
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Pathologic Processes
Neuromuscular Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors