The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Foveal Involving Edema and Lipid Exudates
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months
研究概览
简要总结
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
详细描述
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
Consented, enrolled subjects will receive multiple open-label intravitreal injections on 0.3mg ranibizumab administered every 30 days for 12 months per the treatment algorithm.
The patients will be randomized to 1 of 2 treatment groups. Group 1: Treatment algorithm based on the Diabetic Retinopathy Clinical Research (DRCR) protocol I 4:2:7 strategy based on the presence of macular edema.
Group 2: Continue treatment until not only the macular edema is resolved but also until the lipid exudate is resolved.
Sample size: 30 eyes Follow-up Schedule: Every 4 weeks throughout the study.
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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Diabetic macular edema treatment group (Group 1)
Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
干预措施: ranibizumab 0.3mg (Drug)
Diabetic macular edema and lipid treatment group (Group 2)
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.
干预措施: ranibizumab 0.3mg (Drug)
结局指标
主要结局
Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months
时间窗: 6-12 months
Compare Group 1 and Group 2 for best correct visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters.
次要结局
- Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography(12 months)
- Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability(12 months)
- Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography(12 months)
- Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography(12 months)
- Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography(12 months)
- Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography(12 months)
- Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography(12 months)
- Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability(12 months)
研究者
Julie Gasperini, M.D.
Medical Doctor
South Coast Retina Center; Carson, McBeath, Boswell, Inc.