Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events for diabetic retinopathy subjects who receive intravitreal Aflibercept
研究概览
简要总结
The PRIME trial will assess the safety of 2 mg intravitreal aflibercept injections (IAI) to achieve and maintain DRSS improvements (2 or more steps) in patients with a baseline DRSS level of 47A to 71A inclusive through 104 weeks as determined by reading center determined DRSS gradings on OPTOS fundus photos and leakage index on OPTOS WF-FA.
详细描述
Study eyes will be assigned randomly (1:1 ratio) to one of the following 2 treatment arms. Randomization of PDR subjects will be limited to 50% of each arm.
Group 1
Year 1 Subjects will be seen every month, 28 days (+ 7 days), for 52 weeks. All subjects will receive IAI at baseline, after eligibility is confirmed. Week 4 through week 48, subjects will be seen monthly and treated with IAI PRN (pro re nata) according to, same day, central reading center (CRC) determined DRSS level. Monthly treatment with IAI will continue until a greater than or equal to 2 step DRSS level improvement is achieved, relative to screening/baseline DRSS based on CRC assessment OPTOS fundus photos (FP). Subjects who have baseline proliferative diabetic retinopathy (PDR) (DRSS Level 61-71) will continue to receive monthly IAI until a greater than or equal to 2 step DRSS improvement is achieved as determined by CRC assessment of OPTOS fundus photos relative to screening/baseline DRSS, and PDR is quiescent according to the treating investigator. Treatment with IAI will be reinitiated if a 1 step worsening of DRSS occurs compared to best DRSS score achieved, determined by CRC evaluation of OPTOS fundus photos. If such worsening is detected, the subject would resume monthly IAI until best DRSS score or greater is achieved, as determined by CRC assessment of OPTOS fundus photos. In addition, retreatment will also be re-started if new onset neovascularization is identified and is continued until the PDR is quiescent according to the treating investigator.
Year 2 Beginning in year 2 (week 52) subjects will be seen every 56 days (+ 14 days) and treated with IAI PRN (pro re nata) utilizing the same criteria from year 1. All subjects will have a mandatory week 104 visit, where treatment will not be given.
Group 2
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
- 否
入选标准
- •Men or Women > 18 years of age with type 1 or II diabetes mellitus
- •Diabetic Retinopathy, DRSS Level 47A to 71A, as assessed by CRC (enrollment of PDR levels will be limited to 50% of the total population)
- •BCVA in the study eye better than 20/800
排除标准
- •Any prior systemic anti-VEGF treatment or IVT anti-search vascular endothelial growth factor (VEGF) treatment in the study eye within 24 weeks of screening/baseline
- •Any intravitreal or peribulbar corticosteroids in the study eye within 12 weeks of screening/baseline
- •Any prior treatment with Ozurdex or Iluvien in the study eye
- •SD-OCT central subfield thickness (CST) > 320 µm in the study eye
- •Central DME causing visual acuity loss, in which treatment can not be safely deferred for at least 6 months, in the investigator's judgment
- •Current visually significant vitreous hemorrhage in the study eye. Vitreous hemorrhage is allowed as long as DRSS level is 71A or lower.
- •History of panretinal photocoagulation (PRP) in the study eye
- •History of vitrectomy surgery in the study eye
- •Cataract surgery in the study eye within 8 weeks of screening/baseline
- •Pregnant or breast-feeding women
- •Sexually active men* or women of childbearing potential** who are unwilling to practiceadequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening/baseline; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).
- •* Contraception is not required for men with documented vasectomy.
- •** Postmenopausal women must be amenorrheic for at least 52 weeks in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
- •If currently receiving diaylisis, must have started treatment more than 12 weeks prior to screening/baseline
- •Uncontrolled blood pressure (defined as > 190/110 mm Hg systolic/diastolic, while seated)
研究组 & 干预措施
Group 1
Treatment based on central reading center reading evaluation of DRSS (diabetic retinopathy severity scale) level based on OPTOS funds photos.
干预措施: Aflibercept Injection (Drug)
Group 2
Treatment based on central reading center reading evaluation of DRSS (diabetic retinopathy severity scale) level based leakage index of OPTOS wide field fluorescein angiography.
干预措施: Aflibercept Injection (Drug)
结局指标
主要结局
Incidence of Adverse Events for diabetic retinopathy subjects who receive intravitreal Aflibercept
时间窗: 104 weeks
Assess the safety of 2 mg intravitreal aflibercept injections (IAI) to achieve and maintain DRSS improvements (2 or more steps) in patients with a baseline DRSS level of 47A to 71A inclusive as determined by reading center determined DRSS gradings on OPTOS fundus photos and leakage index on OPTOS WF-FA
次要结局
- ETDRS-BCVA change(104 weeks)
- Mean number of IAI (NPDR VS PDR)(104 weeks)
- Changes in Visual Function(104 weeks)
- Correlation of DRSS and leakage index(104 weeks)
- Correlation between Reading Center DRSS Level and Physician determined DR severity(104 weeks)
- Number of IAI(104 weeks)
- DRSS Change(104 weeks)
- Change in Non-Perfusion(104 weeks)
- Change in Vascular Leakage(104 weeks)
- Change in microaneurysms(104 weeks)
- Change in CST(104 weeks)
- DME development(104 weeks)
- PDR Development(104 weeks)
- Cytokine Levels(104 weeks)