A Randomized, Double-masked, Multicenter, Laser Controlled Phase III Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) as Adjunctive and Monotherapy in Patients With Visual Impairment Due to Diabetic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 396
- 试验地点
- 2
- 主要终点
- Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline)
研究概览
简要总结
This study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in Asian patients with visual impairment due to Diabetic Macular Edema (DME).
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
- Double (Participant, 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 (ADA) or World Health Organization (WHO) guidelines with HbA1c not more than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes.
- •Patients with visual impairment due to focal or diffuse Diabetic Macular Edema 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 for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for study treatment.
- •The study eye must fulfill the following criteria at Visit 1:
- •Best-Corrected Visual Acuity (BCVA) score between 78 and 39 letters, inclusively, using Early Treatment of Diabetic Retinopathy (ETDRS) chart-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160).
- •Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator.
- •Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.
排除标准
- •Ocular concomitant conditions/ diseases:
- •Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment.
- •Active intraocular inflammation in either eye.
- •Any active infection in either eye.
- •History of uveitis in either eye.
- •Uncontrolled glaucoma in either eye.
- •Ocular treatments:
- •Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study.
- •Focal/grid laser photocoagulation in the study eye within 3 months prior to study entry.
- •Systemic conditions or treatments:
- •History of stroke
- •Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine level > 2.0 mg/dL.
- •Untreated diabetes mellitus
- •Blood pressure systolic > 160 mmHg or diastolic > 100 mmHg
- •Compliance/ Administrative:
- •Pregnant or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Adjunctive treatment
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
干预措施: Ranibizumab (Drug)
Adjunctive treatment
Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
干预措施: Laser photocoagulation (Procedure)
Monotherapy treatment
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
干预措施: Ranibizumab (Drug)
Monotherapy treatment
Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
干预措施: Sham laser photocoagulation (Procedure)
Laser control
Active laser treatment plus sham intravitreal injections.
干预措施: Laser photocoagulation (Procedure)
Laser control
Active laser treatment plus sham intravitreal injections.
干预措施: Sham ranibizumab (Drug)
结局指标
主要结局
Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From Month 1 to Month 12 Compared to Baseline)
时间窗: 12 months
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement.
次要结局
- Percent of Participants With Anatomical Changes in Intra-retinal Cysts at End of Study Compared to Baseline(Up to 12 months)
- Percent of Participants With Anatomical Changes in Sub-retinal Fluid at End of Study Compared to Baseline(Up to 12 months)
- Percent of Participants Who Gained >= 10 Letters at Month 12 Compared to Baseline(12 months)
- Change From Baseline on Central Retinal Subfield Thickness (CRST) at Month 12(12 months)
- Patient Outcome Measure Euro Quality of Life Questionnaire (EQ-5D)(12 months)
- Percent of Participants With Visual Acuity Above 73 Letters at Month 12(12 months)
- Percent of Participants Who Lost >= 10 Letters at Month 12 Compared to Baseline(12 months)
- Percent of Participants Who Gained >= 15 Letters at Month 12 Compared to Baseline(12 months)
- Best-Corrected Visual Acuity (BCVA) Mean Change From Baseline at Month 12(12 months)
- Percent of Participants Who Lost >= 15 Letters at Month 12 Compared to Baseline(12 months)