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.
Nonarteritic Anterior Ischemic Optic Neuropathy
|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)|
- 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 ]
- 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 ]
|Study Start Date:||November 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
0.5mg ranibizumab given intravitreally as needed after initial treatment
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.
|United States, Colorado|
|Rocky Mountain Lions Eye Institute|
|Aurora, Colorado, United States, 80045-0510|
|Principal Investigator:||Naresh Mandava, MD||Rocky Mountain Lions Eye Institute, University of Colorado Health Sciences Center|