Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab (ROTATE Trial)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Severity of ocular and systemic adverse events will be compared between experimental and active comparator groups
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 persistent Diabetic Macular Edema (DME) after recent and frequent bevacizumab (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at least 6 bevacizumab injections within 9 months of enrollment).
详细描述
30 eyes will be randomized in a 1:2 ratio (Group A= 10 patients; Group B= 20 patients) Group A: ("monthly group")- Consented patient with enrolled eye will receive 12 monthly required injections of 0.3mg ranibizumab over 1 year OR Group B: ("As needed (PRN) Group")- Consented patient with enrolled eye will receive 6 monthly required injections of 0.3mg ranibizumab for 6 months, followed by as needed (PRN) dosing (required ranibizumab if DME persistent on Optical Coherence Tomography (OCT) and Early Treatment Diabetic Retina Study (ETDRS) Best Corrected Visual Acuity (BCVA) <20/20) for 6 months.
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.
- •>=18 years
- •Type I/II diabetes mellitus
- •Central-involved DME in study eye (OCT CSF >=275um on Heidelberg Spectralis spectral domain OCT with evidence of intraretinal or subretinal fluid or cysts)
- •Definite retinal thickening due to diabetic macular edema involving the center of the macula.
- •Media clarity, pupillary dilation and individual cooperation for adequate fungus photography and fluorescein angiography.
- •Visual Acuity score in study eye <=80 and >=20 (approximate Snellen equivalent 20/25 to 20/400).
- •History of at least 6 intravitreal bevacizumab injections within the past 9 months and 2 intravitreal bevacizumab injections within the past 2 months.
- •No history of an anti-VEGF treatment for DME in the past 3 weeks.
- •No other DME treatment for DME, other than bevacizumab, in the study eye at any time in the past 3 months.
- •No history of major ocular surgery in the study eye within prior 3 months or anticipated within the next six months following randomization.
排除标准
- •Pregnancy or lactation
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Participation in another medical investigation or trial within 30 days of randomization
- •Known allergy to ranibizumab
- •Acute cardiovascular event requiring hospitalization within the past 3 months
- •Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization or anticipated use during the study
- •Macular edema is considered to be due to a cause other than DME
- •An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from the resolution of macular edema
- •History of intravitreal anti-vascular endothelial growth factor (anti-VEGF) agent other than bevacizumab within 9 months prior to randomization
- •History of panretinal photocoagulation within 3 months prior to randomization or anticipated need for panretinal photocoagulation in the 6 months following randomization
- •Yag capsulotomy performed within 1 month prior to randomization
- •External ocular infection including conjunctivitis, significant blepharitis, etc.
研究组 & 干预措施
Ranibizumab 0.3mg (12 months)
Intravitreal injection of ranibizumab 0.3mg/0.05cc
干预措施: Ranibizumab 0.3mg/0.05cc (Drug)
Ranibizumab 0.3mg (6 months)
Intravitreal injection of ranibizumab 0.3mg/0.05cc
干预措施: Ranibizumab 0.3mg/0.05cc (Drug)
结局指标
主要结局
Severity of ocular and systemic adverse events will be compared between experimental and active comparator groups
时间窗: 1 year
Examples include worsened acuity of greater than 30 letters, retinal detachment, endophthalmitis, cataract progression, vitreous hemorrhage, new PDR or neovascularization of the iris or angle, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs and will include thromboembolic events, deaths and systemic serious adverse events
Incidence of ocular and systemic adverse events will be compared between experimental and active comparator groups
时间窗: 1 year
Examples include worsened acuity of greater than 30 letters, retinal detachment, endophthalmitis, cataract progression, vitreous hemorrhage, new PDR or neovascularization of the iris or angle, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs and will include thromboembolic events, deaths and systemic serious adverse events
次要结局
- Efficacy of monthly and monthly followed by PRN dosing of 0.3 mg ranibizumab after persistent DME despite previous bevacizumab therapy(1 year)
研究者
Dennis M. Marcus, M.D.
Dr. Dennis M. Marcus Principal Investigator
Southeast Retina Center, Georgia