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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Fraser Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Fraser Health
ClinicalTrials.gov Identifier:
NCT01607671
First received: May 25, 2012
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Optic Neuropathy, Ischemic
Anterior Ischemic Optic Neuropathy
Ischemic Optic Neuropathy
Optic Neuropathy, Anterior Ischemic
Drug: Timolol maleate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • Recruitment Rate of patients during the one year study to assess feasibility of a larger study [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This is to define the feasabilty of the study design for a larger study.

  • Number of patients with adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    This will evaluate the change in visual acuity as a measure of visual function.

  • Change in the mean deviation of actual versus predicted sensitivity of the visual field. [ Time Frame: 48 hours after enrollment, 1 month, 3 months ] [ Designated as safety issue: No ]
    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.

  • Change in Colour vision as measured by HRR colour plates. [ Time Frame: Within 48 hours of enrollment, 1 month, 3 months ] [ Designated as safety issue: No ]
    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.

  • Change in contrast sensitivity will be measured using the Pelli-Robson contrast sensitivity chart. [ Time Frame: 48 hours from enrollment, 1 month, 3 months. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: June 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01607671

Contacts
Contact: Martin A SuttonBrown, MD 604-582-4561 martin.suttonbrown@fraserhealth.ca

Locations
Canada, British Columbia
Jim Pattison Outpatient Care and Surgery Centre, 3C Neurology Not yet recruiting
Surrey, British Columbia, Canada, V3T 0G9
Contact: Martin A SuttonBrown, MD    604-582-4561    martin.suttonbrown@fraserhealth.ca   
Principal Investigator: Martin A SuttonBrown, MD         
Sponsors and Collaborators
Fraser Health
Investigators
Principal Investigator: Martin A SuttonBrown, MD Fraser Health Region
  More Information

Publications:
Responsible Party: Fraser Health
ClinicalTrials.gov Identifier: NCT01607671     History of Changes
Other Study ID Numbers: NAION-001
Study First Received: May 25, 2012
Last Updated: May 29, 2012
Health Authority: Canada: Health Canada

Keywords provided by Fraser Health:
Ischemic
Optic Neuropathy
Non-Arteritic Anterior Ischemic Optic Neuropathy
NAION
Ischemic Optic Neuropathy
Intraocular Pressure

Additional relevant MeSH terms:
Ischemia
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Peripheral Nervous System Diseases
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Neuromuscular Diseases
Timolol
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014