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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00561834
First received: November 19, 2007
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Nonarteritic Anterior Ischemic Optic Neuropathy
Drug: ranibizumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy (NAION)

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • To determine the mean change in best corrected visual acuity at 6 months in NAION patients treated as needed with ranibizumab. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in VA at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • percentage of patients that lose ≤ 15 letters at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • percentage of patients gaining > 0 letters at 3 months and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • percentage of patients with improvement in visual fields at 3 months, 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • percentage of patients with a resolution of edema on Ocular Coherence Tomography (OCT) at 3 months and at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of injections needed in 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evaluate ocular adverse events at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: November 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab Drug: ranibizumab
0.5mg ranibizumab given intravitreally as needed after initial 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • patients with 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561834

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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00561834     History of Changes
Other Study ID Numbers: 07-0446, genentech FVF4256s
Study First Received: November 19, 2007
Last Updated: October 22, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Ischemia
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Neuromuscular Diseases
Nervous System Diseases
Pathologic Processes
Cranial Nerve Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014