Combination Therapy for PDR
试验速览
- 阶段
- 2 期
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG
研究概览
简要总结
In this randomized 3-armed clinical trial, 105 eyes with PDR will be included and divided randomly into 3 groups: IVB group (35 eyes) that receive 4 monthly IVB injections and then rescue IVB, PRP group (35 eyes) that undergo full PRP in 2 or 3 sessions and then rescue IVB, and combination group (35 eyes) that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser. Diabetic macular edema (DME) will be treated independently in all groups by IVB. Primary outcome will be the number and activity of neovascularizations at 4,8 and 12 months and secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.
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
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •Presence of PDR with the indication of full PRP according the intend of investigator
- •Best corrected visual acuity of 20/320 or better
- •Media clarity, pupillary dilation and patient's cooperation sufficient for full PRP, wide-field FAG and OCT
排除标准
- •History of prior PRP with more than 100 burns outside the posterior pole
- •Tractional retinal detachment involving the macula
- •Evidence of neoplasia of angle on examination
- •Macular edema due to a cause other than DME
- •Any ocular condition which may change visual acuity during the study
- •Substantial cataract which has declined the vision by 3 lines or more
- •History of intravitreal injection of anti-VEGF agent in past 2 months
- •History of any use of corticosteroid during past 4 months
- •History of major intra-ocular surgery except cataract surgery
- •History of YAG laser capsulotomy during past 2 months
- •Aphakia and uncontrolled glaucoma according to investigator judgment
研究组 & 干预措施
intravitreal bevacizumab injections and then rescue
干预措施: receive 4 monthly IVB injections and then rescue IVB (Drug)
PRP group
干预措施: PRP group (Drug)
IVB injections and a modified laser
干预措施: IVB injections and a modified laser (Drug)
结局指标
主要结局
Extent of neovascular tissues in disc-diameter measured by investigator according to the wide-field FAG
时间窗: 12 months
Number of neovascular tissue counted by investigator according to FAG
次要结局
- Best corrected visual acuity based on Snellen chart(12 months)
- Central retinal thickness according to macular OCT(12 months)
研究者
Zahra Rabbani Khah
Head of ophthalmic research center
Shahid Beheshti University of Medical Sciences