Clinical trial NCT01607671: Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5%
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
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
Lead sponsor: Fraser Health
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 0
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Recruitment Rate of patients during the one year study to assess feasibility of a larger study
timeFrame: 12 months
measure: Number of patients with adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Change in visual acuity at enrollment and three month follow up using a logMAR scale.
timeFrame: Enrolment, Within 48 hours of enrollment , 1 month, 3 months.
measure: Change in the mean deviation of actual versus predicted sensitivity of the visual field.
timeFrame: 48 hours after enrollment, 1 month, 3 months
measure: Change in Colour vision as measured by HRR colour plates.
timeFrame: Within 48 hours of enrollment, 1 month, 3 months
measure: Change in contrast sensitivity will be measured using the Pelli-Robson contrast sensitivity chart.
timeFrame: 48 hours from enrollment, 1 month, 3 months.
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Jim Pattison Outpatient Care and Surgery Centre, 3C Neurology
state: British Columbia
Study officials:
affiliation: Fraser Health Region
name: Martin A SuttonBrown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.