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

Ischemic Optic Neuropathy Clinical Trial

Official title:

Can Urgent Reduction of Intraocular Pressure With Ophthalmic Timolol Improve Recovery From Non-arteritic Anterior Ischemic Optic Neuropathy (NAION): a Randomized Study.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01607671
• Other study ID #: NAION-001
• Status: Withdrawn
• Phase: Phase 1
• First received: May 25, 2012
• Last updated: May 22, 2015
• Start date: June 2012
• Est. completion date: November 2013

Study information

• Verified date: May 2012
• Source: Fraser Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Ischemic Optic Neuropathy
• Ischemia
• Ischemic Optic Neuropathy
• Optic Nerve Diseases
• Optic Neuropathy, Anterior Ischemic
• Optic Neuropathy, Ischemic
• Peripheral Nervous System Diseases

Intervention

Drug:
• Timolol maleate
Timolol 0.5% 1 drop twice daily to the effected eye for 4 weeks.

Locations

Country	Name	City	State
Canada	Jim Pattison Outpatient Care and Surgery Centre, 3C Neurology	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fraser Health

Country where clinical trial is conducted

Canada, 

References & 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. Review. — View Citation

Glucksberg MR, Dunn R. Direct measurement of retinal microvascular pressures in the live, anesthetized cat. Microvasc Res. 1993 Mar;45(2):158-65. — View Citation

Mäepea O. Pressures in the anterior ciliary arteries, choroidal veins and choriocapillaris. Exp Eye Res. 1992 May;54(5):731-6. — View 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. — View Citation

Wilhelm B, Lüdtke 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. Epub 2005 Sep 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Number of patients with adverse events		12 months	Yes
Secondary	Change in visual acuity at enrollment and three month follow up using a logMAR scale.	This will evaluate the change in visual acuity as a measure of visual function.	Enrolment, Within 48 hours of enrollment , 1 month, 3 months.	No
Secondary	Change in the mean deviation of actual versus predicted sensitivity of the visual field.	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	No
Secondary	Change in Colour vision as measured by HRR colour plates.	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	No
Secondary	Change in contrast sensitivity will be measured using the Pelli-Robson contrast sensitivity chart.	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.	No