Panretinal photocoagulation vs panretinal photocoagulation with single injection of intravitreal anti-vascular endothelial growth factor for the treatment of proliferative diabetic retinopathy: a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- 1. Patterns of regression of retinal neovascularization
研究概览
简要总结
This study is a randomized controlled trial, comparing the efficacy of a single intravitreal anti-VEGF injection (ranibizumab) plus panretinal photocoagulation against panretinal photocoagulation monotherapy. The primary objective is to compare the regression patterns of retinal neovascularization between panretinal photocoagulation alone and anti-VEGF with panretinal photocoagulation in patients with proliferative diabetic retinopathy. The secondary objectives are to compare - the visual acuity differences, differences in central subfiled thickness, the incidence rates of vitreous hemorrhage, epiretinal membrane, and tractional retinal detachment, and the need for pars plana vitrectomy. These objectives will be assessed at 6 weeks, 3 months and 6 months after last sitting of retinal photocoagulation. The study will help us to answer if adding a single injection of ranibizumab helps in decreasing the risk of progression to advanced proliferative diabetic retinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals with diabetes (type 1 or type 2)
- •Age more than or equal to 18 years
- •Proliferative diabetic retinopathy which the treating physician intends to manage with PRP .
- •Media clarity, pupillary dilation, and individual cooperation sufficient to administer PRP and obtain adequate fundus photographs and OCT.
排除标准
- •Ocular exclusion criteria
- •History of prior PRP
- •Centre involving diabetic macular edema (central subfield thickness of more than or equal to 290µm in women, 305µm in men) (OCT shall be done on Zeiss Cirrus 500)
- •History of receiving intravitreal anti-VEGF or steroid injections in the previous 4 months
- •Macular tractional retinal detachment
- •Presence of vitreous haemorrhage dense enough to preclude successful completion of PRP (as per decision of treating physician)
- •History of prior vitrectomy surgery Systemic exclusion criteria
- •Poor diabetes control (HbA1C more than 12 percent)
- •Poor systemic condition (end stage renal disease on dialysis or other diseases which the treating physician feels can have a significant contribution to the progression of diabetic retinopathy)
- •Inability to follow up at regular intervals.
结局指标
主要结局
1. Patterns of regression of retinal neovascularization
时间窗: 6 weeks, 3 months, 6 months post last PRP session
2. Completeness of PRP and the need for additional laser
时间窗: 6 weeks, 3 months, 6 months post last PRP session
3. Central subfield thickness
时间窗: 6 weeks, 3 months, 6 months post last PRP session
4. Occurrence of new onset macular edema, vitreous haemorrhage, tractional retinal detachment and epiretinal membranes
时间窗: 6 weeks, 3 months, 6 months post last PRP session
次要结局
- Completeness of PRP and the need for additional laser(6 weeks, 3 months, 6 months post last PRP session)
- Central subfield thickness(6 weeks, 3 months, 6 months post last PRP session)
- Occurrence of new onset macular edema, vitreous haemorrhage, tractional retinal detachment and epiretinal membranes(6 weeks, 3 months, 6 months post last PRP session)
- Visual acuity differences(6 weeks, 3 months, 6 months post last PRP session)
- Need for PPV(6 weeks, 3 months, 6 months post last PRP session)
研究者
SHREYAS S TEMKAR
JIPMER