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临床试验/NCT01102946
NCT01102946已完成2 期

Panretinal Photocoagulation Versus Panretinal Photocoagulation Plus Intravitreous Ranibizumab for High Risk Proliferative Diabetic Retinopathy

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Fluorescein leakage area (mm2)

研究概览

简要总结

The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old
  • High risk proliferative diabetic retinopathy
  • Visual acuity ≥ 20/800
  • No previous laser treatment for diabetic retinopathy

排除标准

  • Previous pars plana vitrectomy
  • Systemic thrombo-embolic events
  • Uncontrolled systemic hypertension
  • Conditions avoiding adequated documentation
  • Previous eye surgery in the last 6 months before inclusion in the study

研究组 & 干预措施

PRP plus ranibizumab

Experimental

Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab

干预措施: Ranibizumab (Drug)

PRP plus ranibizumab

Experimental

Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab

干预措施: Panretinal Photocoagulation (Procedure)

PRP

Active Comparator

Patients will only be submitted to panretinal photocoagulation

干预措施: Panretinal Photocoagulation (Procedure)

结局指标

主要结局

Fluorescein leakage area (mm2)

时间窗: Week 48 after inclusion in the study

Neovascularization area measured during fluorescein agiography middle phase

次要结局

  • CMT(Week 48 after inclusion in the study)
  • LogMAR BCVA(Week 48 after inclusion in the study)
  • Retina mid periphery visual field sensitivity change(Week 48 after inclusion in the study)
  • Rod pathway integrity and oscillatory potential amplitudes(Week 48 after inclusion in the study)

研究者

申办方类型
Other

研究点 (1)

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