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临床试验/NCT00443521
NCT00443521已完成2 期

Triamcinolone as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2005年3月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Visual acuity (ETDRS)

研究概览

简要总结

The purpose of the study is to evaluate intravitreal injection of triamcinolone acetonide after laser panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.

详细描述

The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. Therefore this study is designed using both treatments in the same patient: intravitreal triamcinolone plus panretinal photocoagulation in one eye, compared to panretinal photocoagulation alone in the contralateral eye. These patients had their visual acuity measured and complete ophthalmological examination was performed, including macular slit lamp examination, fluorescein angiography and optical coherence tomography.

Patients with symmetric proliferative diabetic retinopathy without high risk characteristics receive laser therapy in both eyes and triamcinolone injections in one eye. For the triamcinolone injections, numbing drops, antibiotic drops, and drops to dilate the pupil, and possibly and anesthetic injection, are put in the eye before the medicine is injected into the vitreous. Patients return for follow-up visits 1 day, 1 and 4 weeks after the injection, and then 3 and 6 months. Patients whose condition does not improve may undergo new evaluation.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type II Diabetes
  • symmetric proliferative diabetic retinopathy without high risk characteristics
  • Informed consent signed

排除标准

  • previous treatment for diabetic retinopathy
  • media opacities that may interfere with clinical, photographically or OCT examinations
  • inability to understands the implications of the protocol
  • Glaucoma or ocular hypertension
  • Any other pathology that could cause retinal alterations
  • Patients with any other situation that may interfere in study completion based in Investigator´s opinion

结局指标

主要结局

Visual acuity (ETDRS)

Optic coherence tomography

Vitreous haemorrhage

次要结局

  • Safety and Tolerance of the treatment

研究者

申办方类型
Other

研究点 (2)

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