Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy (NAION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00561834
Recruitment Status : Completed
First Posted : November 21, 2007
Results First Posted : July 25, 2016
Last Update Posted : September 30, 2016
Genentech, Inc.
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Nonarteritic Anterior Ischemic Optic Neuropathy Drug: ranibizumab Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy (NAION)
Study Start Date : November 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Drug: ranibizumab
All patients (n=15) will be treated with open label 0.5mg ranibizumab given intravitreally monthly as needed for 6 months.

Primary Outcome Measures :
  1. Change in Visual Acuity [ Time Frame: Baseline and 6 months ]
    The mean change in best corrected Snellen visual acuity at 6 months in NAION patients treated as needed with ranibizumab.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00561834

United States, Colorado
Rocky Mountain Lions Eye Institute
Aurora, Colorado, United States, 80045-0510
Sponsors and Collaborators
University of Colorado, Denver
Genentech, Inc.
Principal Investigator: Naresh Mandava, MD Rocky Mountain Lions Eye Institute, University of Colorado Health Sciences Center

Responsible Party: University of Colorado, Denver Identifier: NCT00561834     History of Changes
Other Study ID Numbers: 07-0446
genentech FVF4256s ( Other Identifier: genentech )
First Posted: November 21, 2007    Key Record Dates
Results First Posted: July 25, 2016
Last Update Posted: September 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:
non-arteritic ischemic optic neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Pathologic Processes
Neuromuscular Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents