Additional Effect of Sub-threshold Micro-pulse Laser to Intra-vitreous Injection of Bevacizumab on Diabetic Macular Edema: A Randomized Double-blinded Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline central macular thickness at 2 months
研究概览
简要总结
In this study, all eyes with diabetic macular edema who meet the inclusion criteria and do not meet the exclusion criteria will be included. After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose.
A subthreshold micropulse laser will be performed after the third injection in group A and a sham laser will be performed after the third injection in group B. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns.
The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years diabetic patients
- •Center-involved diabetic macular edema
- •Mean central subfield thickness >300 micrometers
- •Best-corrected visual acuity between 20/40 and 20/400
排除标准
- •hemoglobin A1c > 8
- •High-risk proliferative diabetic retinopathy
- •Prior treatment with intravitreal or peribulbar injections within the preceding 3 months
- •History of panretinal photocoagulation within the former 4 months
- •History of macular photocoagulation
- •Hx of Intraocular surgery (except cataract extraction)
- •cataract extraction less than 6 months ago
- •Macular edema due to a cause other than diabetic retinopathy
- •Any other ocular condition that visual acuity would not improve from the resolution of the edema (eg, foveal atrophy)
- •Substantial cataract estimated to have reduced visual acuity by >3 lines
- •uveitis, neovascular glaucoma, exudative age-related macular degeneration, high risk proliferative diabetic retinopathy
- •vitreomacular traction or epiretinal membrane
- •uncontrolled glaucoma ( > 30 millimeters of mercury with anti-glaucoma medications)
- •Not having: Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
研究组 & 干预措施
Simultaneous intravitreal bevacizumab injection with subthreshold micropulse laser
After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose.
A subthreshold micropulse laser will be performed after the third injection in group A. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns.
The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.
干预措施: Intravitreal bevacizumab injection with subthreshold micropulse laser (Combination Product)
Intravitreal bevacizumab injection alone
After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose.
A sham laser will be performed after the third injection in group B. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns.
The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.
干预措施: Intravitreal bevacizumab injection alone (Drug)
结局指标
主要结局
Change from baseline central macular thickness at 2 months
时间窗: Change from baseline to 2 months
Change from baseline central macular thickness at 2 months using Optical Coherence Tomography
Change from 2 months central macular thickness at 3 months
时间窗: Change from 2 months to 3 months
Change from 2 months central macular thickness at 3 months using Optical Coherence Tomography
Change from 3 months central macular thickness at 4 months
时间窗: Change from 3 months to 4 months
Change from 3 months central macular thickness at 4 months using Optical Coherence Tomography
Change from 4 months central macular thickness at 6 months
时间窗: Change from 4 months to 6 months
Change from 4 months central macular thickness at 6 months using Optical Coherence Tomography
Change from 6 months central macular thickness at 8 months
时间窗: Change from 6 months to 8 months
Change from 6 months central macular thickness at 8 months using Optical Coherence Tomography
Change from 8 months central macular thickness at 10 months
时间窗: Change from 8 months to 10 months
Change from 8 months central macular thickness at 10 months using Optical Coherence Tomography
Change from 10 months central macular thickness at 12 months
时间窗: Change from 10 months to 12 months
Change from 10 months central macular thickness at 12 months using Optical Coherence Tomography
次要结局
- Change from baseline visual acuity at 2 months(Change from baseline to 2 months)
- Change from 2 months visual acuity at 3 months(Change from 2 months to 3 months)
- Change from 3 months visual acuity at 4 months(Change from 3 months to 4 months)
- Change from 4 months visual acuity at 6 months(Change from 4 months to 6 months)
- Change from 6 months visual acuity at 8 months(Change from 6 months to 8 months)
- Change from 8 months visual acuity at 10 months(Change from 8 months to 10 months)
- Change from 10 months visual acuity at 12 months(Change from 10 months to 12 months)
研究者
Zahra Rabbani Khah
Head of Ophthalmic Research Center
Shahid Beheshti University of Medical Sciences