NCT02059772Unknown4 期
Evaluation of an Additional Therapeutic Approach to Diabetic Macular Edema by Combining Standard Therapy (Intravitreal Injection of a VEGF-inhibitor) With Micropulse Diode Laser Treatment in a Randomized, Controlled Proof of Concept Study
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- GWT-TUD GmbH
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- change in best corrected visual acuity (BCVA)
研究概览
简要总结
The primary objective of this study is to evaluate if a combination therapy with micropulse diode laser treatment shows non inferiority on visual acuity within 12 months in comparison to standard therapy (intravitreal injection of ranibizumab only).
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
- •Diagnosis of non-ischemic diabetic macular edema with resulting reduction in visual functionality by determination of best corrected visual acuity (BCVA), ophthalmologic investigation, SD-OCT, FAG and anamnesis
- •BCVA between 0.05 and 0.6 or retinal thickness > 300 µm determined by SD-OCT
- •The informed consent form must be signed before any study specific tests or procedures are done
- •Confirmation of the subject's health insurance coverage prior to the first screening visit
- •Age at least 18 years (inclusive) at the first screening visit
- •Ability to understand and follow study-related instructions
排除标准
- •Severe ischemic maculopathy of the study eye
- •Active neovascularization of iris or retina in the study eye
- •History of intravitreal injection of VEGF-inhibitor or steroids in study eye within the last 3 month
- •Pathologies of the anterior segment of the study eye with reduced visual acuity (e.g. corneal opacification, advanced cataract)
- •Advanced glaucoma with central defects of the visual field in study eye
- •Retinal pathologies with reduced visus (e.g. central scars, age related macular degeneration) in study eye
- •Retinal vascular occlusion in medical history of study eye
- •Active or suspected ocular or periocular infections
- •Active intraocular inflammation in study eye
- •Intraocular surgery of study eye within the last 6 months
- •Laser therapy of study eye within the last 6 months
- •Systemic steroid therapy within the last 3 month
- •HbA1c >10%
- •Systolic blood pressure above 170 mmHg and diastolic blood pressure above 110 mmHg (after at least 3 min in supine position)
- •Pregnant or breast-feeding woman and woman without adequate method of contraception.
- •Known hypersensitivity to the active substance or to any of the excipients
研究组 & 干预措施
Control Group
Experimental
Standard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC
干预措施: ranibizumab (Drug)
Treatment Group
Experimental
Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment
干预措施: ranibizumab (Drug)
Treatment Group
Experimental
Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment
干预措施: micropulse diode laser (Procedure)
结局指标
主要结局
change in best corrected visual acuity (BCVA)
时间窗: baseline, 12 month
次要结局
- change in central macular thickness(baseline, 12 month)
- number of intravitreal Lucentis injections(within 12 month)
研究者
研究点 (1)
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