NCT02107131已完成4 期
Evaluation of ReAding Speed, Contrast Sensitivity, and Work Productivity in Working Individuals With Diabetic Macular Edema Following Treatment With Intravitreal Ranibizumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- A Change Between Two Time Points is Reported for Maximum Reading Speed
研究概览
简要总结
Performance assessment testing may be a useful tool to evaluate the impact of ranibizumab on day-to-day visual function in patients with Diabetic Macular Edema (DME).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age 18 ≤ x ≤ 65 years and currently employed at the baseline study visit
- •Diagnosis of diabetes mellitus (type 1 or 2)
- •o Any one of the following will be considered to be sufficient evidence that diabetes is present:
- •Current regular use of insulin for treatment of diabetes
- •Current regular use of oral anti-hyperglycemia agent for the treatment of diabetes
- •Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy.
- •Central diabetic macular edema present on clinical examination or or evidence indicating disease activity on spectral domain OCT.
- •Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol.
- •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
- •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 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. AMD, uveitis, Irvine-Gas)
- •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.
- •Previous use of intraocular or periocular corticosteroids in the study eye in the previous 120 days
- •Previous treatment with anti-angiogenic drugs in the study eye i.e. pegaptanib sodium, bevacizumab, ranibizumab, aflibercept within 120 days prior to baseline
- •History of vitreous surgery in the study eye
- •History of cataract surgery within 3 months of enrollment.
- •History of YAG capsulotomy within 2 months of enrollment.
- •Visual acuity <20/400 in the fellow eye
- •Uncontrolled glaucoma (pressure >30) despite treatment with glaucoma medications.
- •History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.
研究组 & 干预措施
Monthly Intravitreal ranibizumab 0.3mg
Active Comparator
Monthly Intravitreal ranibizumab 0.3mg injections.
干预措施: Intravitreal ranibizumab 0.3mg (Drug)
PRN Intravitreal ranibizumab 0.3mg
Active Comparator
PRN Intravitreal ranibizumab 0.3mg injections.
干预措施: Intravitreal ranibizumab 0.3mg (Drug)
结局指标
主要结局
A Change Between Two Time Points is Reported for Maximum Reading Speed
时间窗: Month 12
A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed.
次要结局
- Change in Activity Productivity(Month 12)
- Change in Visual Acuity(Month 12)
- Change in Contrast Sensitivity(12 months)
研究者
研究点 (3)
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