Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Central macular thickening
研究概览
简要总结
The purpose of this study is to determine whether topical nepafenac (qid) is effective in preventing and treating macular thickening related pan-retinal photocoagulation in patients with diabetic retinopathy.
详细描述
Objective
To evaluate the effect of topical nepafenac 0.1 %, in preventing and in treating macular thickening related to pan-retinal photocoagulation in diabetic patients. Material and methods: This is a prospective, longitudinal, and controlled study in patients with diabetic retinopathy (severe non-proliferative and proliferative retinopathy), with a symmetric severity in both eyes and without a clinical significant macular edema. The best corrected visual acuity (BCVA) in all patients was 20/80 or better. All patients will undergo pan-retinal photocoagulation in three different sessions (with 2 weeks in apart between them). Each patient will receive topical nepafenac 0.1% (qid) on one eye, and placebo (qid) at the fellow eye, starting 1 week before the first retinal photocoagulation session and continued for 9 weeks ( ending 4 weeks after pan-retinal photocoagulation is completed). Spectral domain OCT and BCVA in ETDRS scale will be performed before and at 2 weeks after each laser session, and at 1, 2 and 3 months after treatment completed. BCVA and OCT outcomes of each studied period will be compared on both eyes, and side effects will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients with Severe and proliferative Diabetic Retinopathy
- •Symmetric severity grade on both eyes
- •Best corrected visual acuity better than 20/80
排除标准
- •Clinical significant macular edema
- •Lens opacity
- •Ocular surgery 6 months or less before recruit
- •Uveitis history
- •Actual use of topical or systemic non-steroidal anti inflammatory agents
- •Actual or history of other macular diseases
- •Ocular surface diseases
- •Vitreomacular traction syndrome
- •Other vascular retinal diseases different to diabetic retinopathy
- •Actual or history of use of topical prostaglandin analogues
研究组 & 干预措施
1: Nepafenac
Topical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed.
干预措施: Nepafenac (Drug)
2: placebo
Topical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed
干预措施: Lubricant (Other)
结局指标
主要结局
Central macular thickening
时间窗: 2 weeks after each laser session and 1 and 2 months after last laser session
次要结局
- Best corrected visual acuity(2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed)