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

August 23, 2016 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045-0510
        • Rocky Mountain Lions Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Naresh Mandava, MD, Rocky Mountain Lions Eye Institute, University of Colorado Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

November 19, 2007

First Submitted That Met QC Criteria

November 19, 2007

First Posted (ESTIMATE)

November 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 30, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0446
  • genentech FVF4256s (OTHER: genentech)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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