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

NCT01607671 | Withdrawn Phase 1

• 1 other identifier: NAION-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Optic Neuropathy, Ischemic; Anterior Ischemic Optic Neuropathy; Ischemic Optic Neuropathy; Optic Neuropathy, Anterior Ischemic

Keywords

Ischemic; Optic Neuropathy; Non-Arteritic Anterior Ischemic Optic Neuropathy; NAION; Ischemic Optic Neuropathy; Intraocular Pressure

Outcome Measures

Primary Outcomes (2)

• Recruitment Rate of patients during the one year study to assess feasibility of a larger study

  This is to define the feasabilty of the study design for a larger study.

  12 months

• Number of patients with adverse events

  12 months

Secondary Outcomes (4)

• Change in visual acuity at enrollment and three month follow up using a logMAR scale.

  Enrolment, Within 48 hours of enrollment , 1 month, 3 months.

• Change in the mean deviation of actual versus predicted sensitivity of the visual field.

  48 hours after enrollment, 1 month, 3 months

• Change in Colour vision as measured by HRR colour plates.

  Within 48 hours of enrollment, 1 month, 3 months

• Change in contrast sensitivity will be measured using the Pelli-Robson contrast sensitivity chart.

  48 hours from enrollment, 1 month, 3 months.

Study Arms (2)

Timolol

EXPERIMENTAL

This group will receive ophthalmic Timolol maleate 0.5%, 1 drop to the effected eye twice daily for 4 weeks.

Drug: Timolol maleate

Standard Care

NO INTERVENTION

This group will be treated with current standard care. This does not include Timolol or other medications to reduce intraocular pressure.

Interventions

Timolol maleate DRUG

Timolol 0.5% 1 drop twice daily to the effected eye for 4 weeks.

Also known as: Timoptic., Timolol., Timolol maleate.

Timolol

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fraser Health: lead

Study Sites (1)

Jim Pattison Outpatient Care and Surgery Centre, 3C Neurology

Surrey, British Columbia, V3T 0G9, Canada

Location

Related Publications (5)

• Atkins EJ, Bruce BB, Newman NJ, Biousse V. Treatment of nonarteritic anterior ischemic optic neuropathy. Surv Ophthalmol. 2010 Jan-Feb;55(1):47-63. doi: 10.1016/j.survophthal.2009.06.008.

  PMID: 20006051 BACKGROUND

• Glucksberg MR, Dunn R. Direct measurement of retinal microvascular pressures in the live, anesthetized cat. Microvasc Res. 1993 Mar;45(2):158-65. doi: 10.1006/mvre.1993.1015.

  PMID: 8361399 BACKGROUND

• Maepea O. Pressures in the anterior ciliary arteries, choroidal veins and choriocapillaris. Exp Eye Res. 1992 May;54(5):731-6. doi: 10.1016/0014-4835(92)90028-q.

  PMID: 1623958 BACKGROUND

• Wilhelm B, Ludtke H, Wilhelm H; BRAION Study Group. Efficacy and tolerability of 0.2% brimonidine tartrate for the treatment of acute non-arteritic anterior ischemic optic neuropathy (NAION): a 3-month, double-masked, randomised, placebo-controlled trial. Graefes Arch Clin Exp Ophthalmol. 2006 May;244(5):551-8. doi: 10.1007/s00417-005-0102-8. Epub 2005 Sep 8.

  PMID: 16151785 BACKGROUND

• Optic nerve decompression surgery for nonarteritic anterior ischemic optic neuropathy (NAION) is not effective and may be harmful. The Ischemic Optic Neuropathy Decompression Trial Research Group. JAMA. 1995 Feb 22;273(8):625-32.

  PMID: 7844872 BACKGROUND

MeSH Terms

Conditions

Optic Neuropathy, Ischemic; Ischemia; Optic Nerve Diseases

Interventions

Timolol

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Martin A SuttonBrown, MD

  Fraser Health Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: May 30, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 25, 2015

Record last verified: 2012-05

Locations

CA (1)