Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Number of injections for each group
研究概览
简要总结
The goal of this pilot study is to investigate the safety and efficacy of micropulse (MP) macular laser in combination with intravitreal aflibercept for the treatment of centre-involved diabetic macular edema.
详细描述
Diabetic macular edema (DME) is one of the major causes of visual decline among diabetic patients. Early Treatment of Diabetic Retinopathy Study has established focal/grid macular laser as the standard of treatment for clinically significant macular edema. More recently, intravitreal injections of anti-VEGF agents, either as monotherapy or in combination with focal/grid laser, have proven to be superior for the treatment of DME compared to laser alone.
Micropulse (MP) macular laser involves applying the laser in a fraction of the time within very small pockets of energy. Unline traditional focal/grid macular laser, the micropulse method of delivery does not leave any visible burns on the retina.
A recent release by the Diabetic Retinopathy Clinical Research Network has shown that deferring focal/grid laser and treating diabetic macular edema with only anti-VEGF may lead to better visual outcomes. Since MP laser does not have the undesired side effect of leaving laser scars on the macula, the study is to show that prompt MP laser in addition to anti-vegf injections may lead to better visual outcomes and/or decreased treatment burden without the undesired side effect of macular scarring.
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, Outcomes Assessor)
盲法说明
Patients and technicians (measuring ocular coherence tomography, fluorescein auto fluorescence and visual acuity) will be masked. The investigator and study coordinator will be unmasked to direct the patient.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type I or Type II Diabetes Mellitus
- •Presence of centre-involved Diabetic Macular Edema (DME) with the Central Macular Thickness (CMT) of ≥ 310µm on the spectral-domain Optical Coherence Tomography (OCT)
- •Best corrected Visual Acuity (BCVA) between, and including, 20/30 and 20/400 in the study eye.
- •Patient's willingness and ability to attend the study visits
排除标准
- •Any other potential causes of macular edema such as active uveitis, epiretinal membrane, post-operative CME, and vitromacular traction
- •Any history of major intraocular surgery (such as cataract surgery or vitrectomy) in the study eye within prior six months, or anticipated need for intraocular surgery within the next six months from the enrollment
- •Any major ocular pathology limiting potential vision such as large macular scars, vitreous hemorrhage, corneal opacities, visually significant cataracts, advanced glaucoma, or other types of optic neuropathy
- •Any history of Panretinal Photocoagulation (PRP) in the study eye or anticipated need for PRP within the next 6 months from enrollment
- •Any history of DME treatment (focal laser, anti-VEGF, or intraocular/periocular steroids) in the study eye in the past 4 months prior to the enrollment
- •Significant renal disease requiring dialysis
- •Significant heart disease, stroke or transient ischemic attack requiring hospitalization in the past 4 months prior to the study
- •Presence of active ocular or periocular infection
- •Presence of active intraocular inflammation
- •Known hypersensitivity to aflibercept or to any ingredient in the formulation or to any component of the container
研究组 & 干预措施
Aflibercept with Micropulse Laser
Aflibercept 2mg (0.05mL) injected intravitreally every 4 weeks or as needed Micropulse Laser at initial visit and reassessed every 12 weeks.
干预措施: Micropulse Laser (Combination Product)
Aflibercept with Sham Laser
Aflibercept 2mg (0.05mL) injected intravitreally every 4 weeks or as needed Sham Laser at initial visit and reassessed every 12 weeks.
干预措施: Sham Laser (Device)
结局指标
主要结局
Number of injections for each group
时间窗: 48 weeks
Number of intravitreal injections for each group
次要结局
- Proportion of eyes with 2 or 3 lines of visual gain or loss(48 weeks)
- Proportion of eyes that achieve 20/20 vision(48 weeks)
- Proportion of eyes that have PRP, vitreous hemorrhage, and vitrectomy.(48 weeks)
- Changes in visual acuity(48 weeks)
- Number of injections half way(24 weeks)
- Proportion of eyes that had vision or OCT improvement(48 weeks)
- Changes in OCT Central Macular Thickness and Volume(48 weeks)
研究者
Keyvan Koushan
Principal Investigator
Toronto Retina Institute