Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy

NCT ID: NCT00561834

Last Updated: 2016-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-04-30

Brief Summary

The purpose of this study is to explore the safety and efficacy of ranibizumab to treat non-arteritic ischemic optic neuropathy based on clinical and anatomical findings.

Detailed Description

Nonarteritic anterior ischemic optic neuropathy (NAION) is the most common acute optic neuropathy in people older than 50 years. It is characterized by sudden partial loss of vision in one eye and has an increased risk of vision loss in the fellow eye. Although cause has not been determined, NAION is thought to occur following an idiopathic ischemic event involving the short posterior ciliary arteries that supply blood to the most anterior part of the optic nerve. A complete loss of vision is rare, but partial loss of visual field or acuity can result from NAION in the affected eye(s).

Patients who have a 'disc at risk' or 'crowded disc' (small cup: disc ratio) are at increased risk for developing NAION. Other risk factors for NAION include age > 50 years and white race (estimated 95% of cases). Hypertension and diabetes also predispose to NAION development. Other factors that have been associated with NAION include high cholesterol, arteriosclerosis, stroke, cardiac and intraocular surgery, tobacco use, nocturnal hypotension, blood loss, glaucoma, elevated homocysteine and sleep apnea. The association between NAION and hypertension, high cholesterol and diabetes is stronger in individuals younger than 50 years than in older persons.

Patients with NAION caused by ischemia leading to swelling of the optic nerve and rapidly progressing visual loss have had limited results with therapy such as corticosteroids, brimonidine, levodopa or surgery, such as optic nerve sheath decompression, in the past. Currently, there is no standard of care for these patients.

Although the role of vascular endothelial growth factor (VEGF) in NAION has not been established, ischemic conditions may lead to VEGF production which could be the cause of edema and swelling. This possibility suggests that VEGF may be a target for therapeutic intervention by ranibizumab. Ranibizumab has demonstrated an effect on edema and vascular permeability. In animal studies it has shown a concentration- dependent effect of blunting the vascular permeability induced by VEGF. Of the more than 5,000 subjects with age-related macular degeneration in current and completed clinical trials, vascular permeability and edema have decreased with the use of ranibizumab.

Conditions

Nonarteritic Anterior Ischemic Optic Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ranibizumab

To determine the mean change in best corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study testing system at 6 months in NAION patients treated as needed (PRN) with ranibizumab.

Group Type: EXPERIMENTAL

ranibizumab

Intervention Type: DRUG

All patients (n=15) will be treated with open label 0.5mg ranibizumab given intravitreally monthly as needed for 6 months.

Interventions

ranibizumab

All patients (n=15) will be treated with open label 0.5mg ranibizumab given intravitreally monthly as needed for 6 months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• provide written informed consent
• 21 years of age or older
• new onset, within 14 days, of ischemia and vision loss
• Best Corrected Visual Acuity (BCVA) 20/40 or worse

Exclusion Criteria

• pregnancy or lactation
• proliferative diabetic retinopathy,
• diabetic macular edema,
• uveitis,
• history of ocular trauma,
• severe glaucoma,
• age-related macular degeneration.
• prior or concomitant treatment of oral steroids within 30 days,
• participation in any studies of investigational drugs within 30 days,
• participation in a ranibizumab clinical trial or,
• prior treatment intravitreally or intravenously of Avastin or steroids.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naresh Mandava, MD

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Lions Eye Institute, University of Colorado Health Sciences Center

Locations

Rocky Mountain Lions Eye Institute

Aurora, Colorado, United States

Countries

United States

Other Identifiers

genentech FVF4256s

Identifier Type: OTHER

Identifier Source: secondary_id

07-0446

Identifier Type: -

Identifier Source: org_study_id