NCT01607671

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fraser Health · Academic / Other
• Sex: All
• Age: 41 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Timolol maleate	Timolol 0.5% 1 drop twice daily to the effected eye for 4 weeks.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-05-30
• Last updated: 2015-05-25

Locations

1 site across 1 country: Canada