CTRI/2012/08/002878招募中4 期
A randomized, parallel group, open label, Comparative study of laser photocoagulation with and without intravitreal triamcinolone acetonide in clinically significant macular edema (CSME) in diabetic retinopathy.
Govt medical college and Sir Takhatsinhji General Hospital Bhavnagar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年1月9日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bestcorrecterd Visual Acuity and
研究概览
简要总结
Thisstudy is a randomized, parallel group, open label, comparative study comparingsafety and efficacy of Laser Photocoagulation with and without intravitreal injection Triamcinolone Acetonidein patients with clinically significant macular edema in diabetic retinopathythat will be conducted at single centre in India. The primary outcome measureswill be best corrected visual acuity and intraocular pressure measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of diabetes mellitus ( type or type 2).
- •Age ≥ 18 years.
- •Able and willing to provide informed consent.
- •Definite retinal thicking due to diabetic macular edema based on clinical examination involving the centre of the macula.
- •Media clarity, papillary dilatation, and patient cooperation sufficient For adequate fundus photographs.
- •IOP < 25 mmHg.
排除标准
- •History of chronic renal failure requiring dialysis or kidney transplant.
- •Known allergy to any corticosteroid or any component of the delivery vehicle.
- •History of systemic (e.g. oral, IV, IM, epidural, bursal) corticosteroids within 4 ) months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 2 times per week.
- •Proliferative diabetic retinopathy.
- •Intraocular pressure ≥ 25 mmHg. 8)History of open angle glaucoma.
- •History of steroid-induced intraocular pressure elevation that required IOP lowering agents.
- •History of prior treatment with intravitreal corticosteroids within 6 months prior to randomization.
- •History of focal/grid macular photocoagulation within 15 weeks (3.5 months) prior to randomization.
- •History of panretinal scatter photocoagulation (PRP) within prior 4 months or anticipated within the next 6 months following randomization.
- •History of prior herpetic ocular infection.
- •An ocular condition is present such that visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, nonretinal conditions).
结局指标
主要结局
Bestcorrecterd Visual Acuity and
时间窗: Day 1, Day 7, Weeks 3, Weeks 6, Weeks 12, Weeks 24
Intraocular pressure
时间窗: Day 1, Day 7, Weeks 3, Weeks 6, Weeks 12, Weeks 24
次要结局
- any Adverse events(Day 1, Day 7, Weeks 3, Weeks 6, Weeks 12, Weeks 24)
研究者
研究点 (1)
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