NCT01253694撤回2 期
Ranibizumab in Residual Diabetic Macular Edema Following Previous Intravitreal Bevacizumab Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proportion of subjects with resolution of diabetic macular edema compared to baseline as determined by mean foveal thickness on Spectralis < 300 microns.
研究概览
简要总结
Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to Bevacizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be eligible if the following criteria are met:
- •Age > 18 years
- •Diagnosis of diabetes mellitus (type 1 or 2)
- •Residual edema as determined by mean foveal thickness on Spectralis OCT (optical coherence tomography) > 300 microns and leakage seen on FA at baseline
- •Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy.
- •Previous history of at least 3-5 or more consecutive 1.25 mg of intravitreal bevacizumab injections for the treatment of diabetic macular edema (consecutive injections administered no more than 6 weeks apart).
- •BCVA of 20/32-20/400 using Early Treatment Diabetic Retinopathy Study (ETDRS)
- •Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
排除标准
- •Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
- •Participation in another ocular investigation or trial simultaneously.
- •Systemic use of anti-VEGF within 3 months prior to day
- •Blood pressure > 180/110 (systolic above 180 OR diastolic above 110)
- •Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse).
- •Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema.
- •An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis, ischemic maculopathy or geographic atrophy).
- •Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. Age-related Macular Degeneration, uveitis, Irvine-Gass).
- •Evidence of active neovascularization of the iris or retina.
- •Evidence of central atrophy or fibrosis in the study eye.
- •Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
- •History of vitreous surgery in the study eye.
- •History of cataract surgery within 6 months of enrollment.
- •History of YAG capsulotomy within 2 months of enrollment.
研究组 & 干预措施
Patients with 3-5 consecutive Avastin injections
Experimental
These patients will receive 0.5 mg of intravitreal Ranibizumab monthly for 6 months.
干预措施: injection of 0.5 mg of Intravitreal Ranibizumab (Drug)
Patients with 6 or more consecutive injections of Bevacizumab
Experimental
Patients will receive 0.5 mg of intravitreal Ranibizumab during the first 6 months.
干预措施: injection of 0.5 mg of Intravitreal Ranibizumab (Drug)
结局指标
主要结局
Proportion of subjects with resolution of diabetic macular edema compared to baseline as determined by mean foveal thickness on Spectralis < 300 microns.
时间窗: 6 months
次要结局
- Evaluate the main change in BCVA (best corrected visual acuity) score over time(6-12 months)
研究者
研究点 (1)
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