Anti-VEGF Therapy Versus Dexamethasone Implant for Treatment Naive Diabetic Macular Edema: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity
研究概览
简要总结
We look at a randomized comparative study of 2 FDA approved anti-VEGF agents(aflibercept and ranibizumab) and see how they compare against the dexamethasone implant for phakic as well as pseudophakic eyes with treatment naive diabetic macular edema in terms of efficacy and safety over two years.
详细描述
A randomized, partially masked, observational/interventional trial looking at the efficacy and safety of 2 FDA approved anti-VEGF agents vis-a-vis the dexamethasone implant as primary therapy for treatment naive diabetic macular edema in phakic as well as pseudophakic patients.
Patients with treatment naive clinically significant macular edema will be randomized to receive one of the aforementioned therapies in a 1:1:1 distribution. Primary inclusion criteria are :
Well controlled diabetes(HbA1c<7%) and co-morbidities. Central Subfield Thickness of 300 microns or greater BCVA < or equal to 6/12.
Exclusion Criteria:
Contraindications to the aforementioned drugs Confounding Ocular co-morbidities that can affect visual assessment(except Cataract Grade II or less as per the LOCS III classification) Refusal for enrolment
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Well controlled diabetes(HbA1c<7%) and co-morbidities. Central Subfield Thickness of 300 microns or greater BCVA < or equal to 6/12.
排除标准
- •Contraindications to the aforementioned drugs Confounding Ocular co-morbidities that can affect visual assessment(except Cataract Grade II or less as per the LOCS III classification) Macular ischemia or proliferative Disease Refusal for enrolment
研究组 & 干预措施
Group 1
Aflibercept intravitreal injection for CSME
干预措施: Aflibercept, (Drug)
Group 2
Ranibizumab Intravitreal Injection for CSME
干预措施: Ranibizumab Injection (Drug)
Group 3
Dexamethasone Implant for CSME
干预措施: Ozurdex Drug Implant Product (Drug)
结局指标
主要结局
Best Corrected Visual Acuity
时间窗: 2 years
BCVA measured at baseline and final follow-up
次要结局
- Central Subfield Thickness(2 years)
- Complications(2 years)
- Injection Count(2 years)
研究者
Aditya Sudhalkar
Consultant Vitreoretinal Surgeon
Sudhalkar Eye Hospital