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

NCT ID: NCT01607671

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-11-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Timolol

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

Group Type: EXPERIMENTAL

Timolol maleate

Intervention Type: DRUG

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

Standard Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Timolol maleate

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

Intervention Type: DRUG

Other Intervention Names

Timoptic.; Timolol.; Timolol maleate.

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

• Minimum Eligible Age: 41 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fraser Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin A SuttonBrown, MD

Role: PRINCIPAL_INVESTIGATOR

Fraser Health Region

Locations

Jim Pattison Outpatient Care and Surgery Centre, 3C Neurology

Surrey, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 20006051 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8361399 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1623958 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16151785 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7844872 (View on PubMed)

Other Identifiers

NAION-001

Identifier Type: -

Identifier Source: org_study_id