Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Treatment-Naive Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Macular Evaluation
研究概览
简要总结
To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured by time-domain optic coherence tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).
详细描述
Comparative efficacy of combined treatment including intravitreal injection of 0.5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with Proliferative Diabetic Retinopathy (PDR).
Objectives:
Primary objective:
The primary objective will be to evaluate the efficacy of combined treatment with ranibizumab and laser photocoagulation versus laser photocoagulation alone in patients with severe PDR by the mean change in BCVA at V7/M6 compared to baseline. The Best Visual Acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (EDTRS).
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Naive Proliferative diabetic retinopathy eyes.
- •Best Corrected-Visual Acuity at baseline > 20/320 in the study eye
- •Patients with and without diabetic macular edema
- •Type II diabetic subjects as defined by the World Health Organization aged ≥ 18 years.
- •Women must be using effective contraception
- •Ability to provide written informed consent.
- •Indication of panretinal photocoagulation in both eyes
排除标准
- •Vitreous hemorrhage or pre-retinal hemorrhage
- •Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months
- •Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
- •Any intraocular surgery within 6 months before trial enrollment
- •Previous vitrectomy.
- •Any of the following underlying systemic diseases:
- •History or evidence of severe cardiac disease or previous thrombus-embolic event
研究组 & 干预措施
Ranibizumab
Ranibizumab 0,05 mg intravitreal injection
干预措施: Ranibizumab (Drug)
Ranibizumab
Ranibizumab 0,05 mg intravitreal injection
干预措施: Laser therapy (Procedure)
Laser Therapy
Laser Therapy alone
干预措施: Laser therapy (Procedure)
结局指标
主要结局
Macular Evaluation
时间窗: 6 Months
Changes between visual acuity from baseline to month 6.
次要结局
- Structural Macular Evaluation(06 months)
研究者
Daniel Araujo Ferraz
Ophthalmologist
University of Sao Paulo