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Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy

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赞助商
University of Colorado, Denver
合作者
Genentech, Inc.

关键词

抽象

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.

描述

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.

日期

最后验证: 07/31/2016
首次提交: 11/18/2007
提交的预估入学人数: 11/18/2007
首次发布: 11/20/2007
上次提交的更新: 08/22/2016
最近更新发布: 09/29/2016
首次提交结果的日期: 03/02/2014
首次提交质量检查结果的日期: 06/12/2016
首次发布结果的日期: 07/24/2016
实际学习开始日期: 10/31/2007
预计主要完成日期: 03/31/2009
预计完成日期: 03/31/2009

状况或疾病

Nonarteritic Anterior Ischemic Optic Neuropathy

干预/治疗

Drug: Ranibizumab

相 1

手臂组

干预/治疗
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.

资格标准

有资格学习的年龄 21 Years 至 21 Years
有资格学习的性别All
接受健康志愿者
标准

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.

结果

主要结果指标

1. 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.

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