Monthly Ranibizumab Versus Treat and Extend Ranibizumab for Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.
研究概览
简要总结
This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.
详细描述
This is a prospective randomized study comparing two groups of patients with diabetic macular edema. One group will receive injections of ranibizumab monthly and the other group will have the option to receive injections of ranibizumab less frequently. That is eligible to receive the injections less frequently will have fewer injections given if the patients in that group are doing well.
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
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age > 18 years
- •Patient related considerations
- •Phakic or pseudophakic patients with a known history of diabetes will be eligible.
- •Women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug.
- •Disease related considerations:
- •Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication.
- •Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40
- •Central foveal thickness on SD-OCT of >300um
排除标准
- •Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Participation in another simultaneous medical investigation or trial
- •Foveal ischemia on IVFA
- •Intraocular surgery less than 6 months ago
- •Epiretinal membrane of clinical significance
- •Prior vitrectomy
- •Uncontrolled glaucoma
- •Macular or peripheral laser within 90 Days from Day 0 injection
- •Intravitreal steroid injection within 90 days from Day 0 injection
- •Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection
研究组 & 干预措施
Monthly Ranibizumab
Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
干预措施: Ranibizumab (Drug)
Treat and Extend Ranibizumab
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.
时间窗: Baseline through 24 months
The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.
次要结局
- Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.(24 months)
- Mean Number of Injections.(24 months)
- Percentage of Patients Anatomically "Dry."(24 Months)
- Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).(24 months)