Off-Label,Intravitreal Use of Bevacizumab for Retinal Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Vision change
研究概览
简要总结
Bevacizumab is an anti-VEGF agent used in approved for use in metastatic colorectal carcinoma (FDA Approved). This study analyzes the safety and efficacy of off-label Intravitreal Injection of bevacizumab (Avastin) for CNVM, Macular oedema due to diabetic retinopathy, vascular occlusion and other retinal disorders.
详细描述
Purpose: To study the efficacy and safety of invitreal injection of bevacizumab (avastin) in all the following conditions.
- Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
- Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
- Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
- Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR
- Informed consent were taken from all the patients, based on the guidelines of OMIC (Ophthalmic mutual insurance company)Avastin: Risk management recommendations and consent form.
American Academy of ophthalmology-Risk management recommendations for off-label , Intravitreal use of Avastin.
Included indications, exclusion criteria, possible complications and the off-label status of the drug.
Best corrected visual acuity, Fundus Photography, anterior segment examination, Optical coherence tomography and in selected patients Electrophysiology, VEP and Fundus fluorescein angiography was done according to surgeons discretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
- •Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
- •Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
- •Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.
排除标准
- •Patients with poor compliance
- •Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (< one year). (Physician clearance was obtained for all patients).
- •Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
结局指标
主要结局
Vision change
Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness)
Electrophysiological changes (ERG, VEP)
次要结局
- Ocular side effects (infection, RD, IOP rise, cataract)