NCT03690947已完成4 期
Randomized, Double-blinded, Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Micropulse Laser for the Treatment of Diabetic Macular Edema
Beijing Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity changes
研究概览
简要总结
The objective of this study is to evaluate if combination of intravitreal ranibizumab with micropulse laser shows non inferiority compared to intravitreal ranibizumab only in diabetic macular edema.
详细描述
To investigate the efficacy of intravitreal ranibizumab injections compared to combination with Micropulse Laser in Chinese patients with visual impairment in DME.
The result of the study will be used to support new therapy in DME patients in China.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent form must be signed before any tests or procedures are done
- •Male or female of 30 to 80 years of age (inclusive) at the first screening visit
- •Diagnosis of type 2 diabetes, with fasting blood glucose≤10mmol/L, HbA1C≤10.0%
- •Diabetic medication must be stable for at least 3 months before first screening visit and remain stable during study
- •Diagnosis of non-proliferative diabetic retinopathy with diabetic macular edema resulting in visual acuity reduction
- •Study eye's BCVA between 24 to 78 ETDRS letters at screening and baseline of the study
- •Macular edema of the study eye and central retinal thickness ≥300 µm determined by SD-OCT
- •Study eye had not had grid pattern photocoagulation, intraocular surgery, intravitreal corticosteroid injections and intravitreal anti-VEGF injections for at least 3 months before baseline
- •Non-study eye's BCVA ≥ 24 ETDRS letters at screening and baseline of the study
- •Non-study eye had not had intravitreal anti-VEGF injections for at least 3 months before baseline
- •If both eyes qualify, then investigators will choose an eye with worse BCVA as study eye. Only study eye will receive intravitreal ranibizumab and/or Micropulse Laser treatment
排除标准
- •Failure to follow study or follow-up procedures
- •Pregnant or breast-feeding woman and woman without adequate method of contraception
- •History of stroke or myocardial infarction within 3 months before screening
- •Renal failure or creatinine > 2.0 mg/dl
- •Uncontrolled systemic diseases or systemic treatment that may affect results of the study
- •Active ocular or intraocular infections of either eye
- •Neovascularization of the iris or neovascular glaucoma of either eye
- •A history of uveitis or vitreous macular traction in study eye
- •Glaucoma or IOP≥24 mmHg of study eye
研究组 & 干预措施
Combination Therapy Group
Experimental
干预措施: Intravitreal Ranibizumab (Drug)
Combination Therapy Group
Experimental
干预措施: Micropulse Laser (Procedure)
Intravitreal Ranibizumab Group
Active Comparator
干预措施: Intravitreal Ranibizumab (Drug)
Intravitreal Ranibizumab Group
Active Comparator
干预措施: Intravitreal Ranibizumab as needed (Drug)
结局指标
主要结局
Best Corrected Visual Acuity changes
时间窗: 12 months
Compare the changes of BCVA between two groups
次要结局
- Central Macular Thickness changes(12 months)
研究者
Yu Xiaobing
M.D.
Beijing Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Intravitreal Ranibizumab in Exudative Age-related Macular Degeneration With Posterior Vitreomacular AdhesionNeovascular Age-related Macular DegenerationNCT01291121Yonsei University30
Unknown
4 期
Intravitreal Ranibizumab and TA Combination Therapy vs. Ranibizumab Monotherapy in Polypoidal Choroidal VasculopathyWet Macular DegenerationNCT02806752Aier School of Ophthalmology, Central South University120
Unknown
3 期
Comparison of Intravitreal Ranibizumab and Macular Laser Photocoagulation for ME Following Branch Retinal Vein Occlusion (BRVO)Branch Retinal Vein OcclusionNCT01189526Seoul Retina Investigator Group60
撤回
4 期
Systemic VEGF Protein Dynamics Following Intravitreal Injections of Ranibizumab Versus Aflibercept in Patients With Visual Impairment Due to Diabetic Macular EdemaVisual Impairment Due to Diabetic Macular EdemaNCT02258009Novartis Pharmaceuticals
已完成
1 期
Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic RetinopathyRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetic RetinopathyNCT01746563University of Sao Paulo30