Nonarteritic Anterior Ischemic Optic Neuropathy
Conditions
Keywords
non-arteritic ischemic optic neuropathy, ranibizumab, naion
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.
Interventions
DRUGranibizumab
All patients (n=15) will be treated with open label 0.5mg ranibizumab given intravitreally monthly as needed for 6 months.
Sponsors
Genentech, Inc.
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Acuity | Baseline and 6 months | The mean change in best corrected Snellen visual acuity at 6 months in NAION patients treated as needed with ranibizumab. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Ranibizumab |
|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 4.95 |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Change in Visual Acuity
The mean change in best corrected Snellen visual acuity at 6 months in NAION patients treated as needed with ranibizumab.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Change in Visual Acuity | lines change in visual acuity subject 1 | 4 lines change in Snellen chart |
| Ranibizumab | Change in Visual Acuity | lines change in visual acuity -subject 2 | 3 lines change in Snellen chart |