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

Fraser Health

Status and phase: Withdrawn; Phase 1

Conditions: Optic Neuropathy, Anterior Ischemic; Optic Neuropathy, Ischemic; Ischemic Optic Neuropathy; Anterior Ischemic Optic Neuropathy

Treatments: Drug: Timolol maleate

Study type: Interventional

Funder types: Other

Identifiers

NCT01607671

NAION-001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 41+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Timolol

Experimental group

Description:

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

Treatment:

Drug: Timolol maleate

Standard Care

No Intervention group

Description:

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