A 2 Year Randomized, Single-masked, Multicenter, Controlled Phase IIIb Trial Assessing the Efficacy and Safety of 0.5 mg Ranibizumab in Two "Treat and Extend" Treatment Algorithms vs. 0.5 mg Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 1
- 主要终点
- Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
研究概览
简要总结
The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.
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
- Single (Investigator)
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
- •Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization [WHO] guidelines) with glycosylated hemoglobin (HbA1c) ≤ 12.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes. Treatment for diabetes must have been stable for at least 3 month.
- •Patients with visual impairment due to DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected by the investigator as the study eye.
- •BCVA ≥ 39 and ≤78 letters in the study eye and, inclusively, using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) at screening.
- •Concomitant conditions in the study eye are only permitted if, in the opinion of the investigator, they do not prevent improvement of visual acuity on study treatment.
排除标准
- •Patient Compliance/ Administrative
- •Pregnant or nursing (lactating) women.
- •Ocular medical history
- •Active intraocular inflammation (grade trace or above) in either eye at enrollment.
- •Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye at the time of enrollment.
- •History of uveitis in either eye at any time.
- •Structural damage within 0.5 disc diameter of the center of the macular in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema.
- •Uncontrolled glaucoma in either eye at screening.
- •Prior Ocular treatments
- •Panretinal laser photocoagulation in the study eye within 6 months prior to randomization.
- •Focal/grid laser photocoagulation in the study eye within 3 months prior to randomization.
- •Treatment with anti-angiogenic drugs in either eye.
- •Systemic conditions or treatments
- •History of stroke within 6 months prior to enrollment.
- •Renal failure requiring dialysis.
- •Untreated diabetes mellitus.
- •Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
TE Ranibizumab 0.5 mg and Laser
On Day 1, all patients received an intravitreal injection with 0.5 mg ranibizumab and subsequently entered Phase A which comprised of monthly injections. Laser therapy was applied at Day 1. It could then be re-administered according to ETDRS criteria at any visit with 0.5 mg ranibizumab treatment if deemed necessary by the Treating Investigator with a minimal treatment interval between laser treatments of 3 months. Laser therapy was administered ≥ 30 minutes prior to the ranibizumab injection.
干预措施: Ranibizumab (Drug)
TE Ranibizumab 0.5 mg alone
Patients received ranibizumab intravitreal injection therapy only.
干预措施: Ranibizumab (Drug)
PRN Ranibizumab 0.5 mg
Patients received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 12
时间窗: Baseline to Month 12
Visual acuity was assessed at every study visit for the study eye using best correction determined from protocol refraction. The BCVA measurements were taken in a sitting position using ETDRS-like VA testing charts at a starting distance of 4 meters.
次要结局
- Visual Acuity of the Study Eye: Change From Baseline at Month 12(Baseline and Month 12)
- Visual Acuity of the Study Eye: Change From Baseline at Month 24(Baseline and Month 24)
- Visual Acuity of the Study Eye: Average Change From Baseline to Month 1 Through Month 24(Baseline to Month 24)
- Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 24(Baseline, 24 month)
- Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 24(Baseline and 24 month)
- EuroQoL (EQ-5D) Thermometer Score: Change From Baseline at Month 12 and Month 24(Baseline, Month 12 and Month 24)
- Visual Acuity of the Study Eye: Categorized Change From Baseline at Month 12(Baseline, Month 12)
- Central Subfield Thickness of the Study Eye: Percent Change From Baseline at Month 12(Baseline, Month 12)
- Visual Functioning Questionnaire (VFQ-25) Change From Baseline in Total Score at Month 12 and Month 24(Baseline, Month 12 and Month 24)