Intravitreal Bevacizumab for Non-Arteritic Anterior Ischemic Optic Neuropathy

Sponsor

Mount Sinai Hospital, Canada (Other)

Overall Status

Unknown status

CT.gov ID

NCT00813059

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Non-Arteritic Ischemic Optic Neuropathy (NAION) is a disease producing swelling of the optic nerve (the "cable" going from the eye to the brain) resulting in decreased vision. About 15% of patients will experience NAION in the second eye; many of these patients will be left legally blind.

Currently, there is no treatment for NAION and for patients in whom the second eye becomes involved by the disease the outcome can be devastating.

The investigators are conducting a study where the investigators will inject a medication into the involved eye of patients with NAION. This medication might decrease the swelling of the optic nerve and improve their vision in that eye.

Condition or Disease	Intervention/Treatment	Phase
Non-arteritic Anterior Ischemic Optic Neuropathy	Drug: Intra-vitreal injection of bevacizumab (1.25mg/0.05ml)	Phase 2

Detailed Description

NAION produces an ischemic insult in the optic nerve head presumably due to the hypoperfusion of the short ciliary arteries that supply it. This leads to the release of vascular endothelial growth factor (VEGF) and swelling of the affected area of the nerve. Vascular endothelial growth factor (VEGF) causes a rapid and reversible increase in vascular permeability and thus vasogenic edema of the affected area of the optic nerve head. Subsequently, increased pressure from the swelling of the affected segment causes compression and infarction of the previously not affected parts of the optic nerve by creating a sort-of "compartment syndrome".

Bevacizumab is a known anti-Vascular Endothelial Growth Factor (VEGF) agent. It is the investigators hypothesis that by injecting bevacizumab intra-vitreally the vasogenic edema will be reduced, preserving viable but threatened optic nerve tissue. One recent case report described a patient with sequential NAION treated with intra-vitreal bevacizumab who demonstrated significant improvement in visual acuity and on visual field testing (1). An editorial in the same issue of the Journal of Neuro-Ophthalmology in which this article appeared suggested that if the small studies evaluating intra-vitreal injections of bevacizumab in NAION would support its use in this disease, a large multi-center trial could be planned (2).

Intra-vitreal injections of bevacizumab have proven to be very safe in treatment of age-related macular degeneration (3). Because the patients that the investigators are planning to enroll in this study are faced with the real possibility of blindness with no therapeutic modality currently available to improve their visual outcome, the investigators believe that offering them intra-vitreal bevacizumab injection that might halt the progression of the visual acuity and visual field loss if our hypothesis is correct, would greatly improve their chances of avoiding blindness.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intravitreal Bevacizumab for Treatment of the Second Eye With Non-Arteritic Ischemic Optic Neuropathy

Study Start Date :

Feb 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2012

Anticipated Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Intra-vitreal injection of bevacizumab (1.25mg/0.05ml) Pars plana intra-vitreal injection of bevacizumab (1.25 mg/0.05 ml)

Arm

Intervention/Treatment

Experimental: 1

Drug: Intra-vitreal injection of bevacizumab (1.25mg/0.05ml)

Pars plana intra-vitreal injection of bevacizumab (1.25 mg/0.05 ml)

Outcome Measures

Primary Outcome Measures

Percentage of patients who gained three or more lines of vision at six months [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with newly diagnosed NAION (within the past 30 days but preferably within the first 14).

Exclusion Criteria:

Patients who are unable to give informed consent
Patient with:
uncontrolled glaucoma
pregnancy
lactation
proliferative diabetic retinopathy
active clinically significant diabetic macular edema
active uveitis
prior treatment with intraocular steroids that incited significant increase in intra-ocular pressure
other known causes of decreased visual acuity in the recently involved eye such as significant dry or wet macular degeneration
previous history of other optic neuropathies
previous history of ocular trauma that resulted in decreased visual acuity
Patients with baseline amblyopia in the newly involved eye and visual acuity worse than 20/50 prior to the onset of NAION
Previous treatment for any ocular condition with any investigational drugs