Aflibercept anD navigateD vErsus coNvensional Laser in Diabetic macUlar edeMa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Percentage of eyes that received additional aflibercept injections after laser at month 12 in group A and B
研究概览
简要总结
Diabetic macular edema (DME) in diabetic retinopathy (DR) is the leading cause of visual impairment among the 300,000 Danish patients with diabetes (DM) and will in time affect 29% of patients. Because of DME, 550 intravitreal injections were given at Odense University Hospital in 2014 with medicine expenses approximating 3.3 million DKK. With an increasing prevalence of diabetes, the number is expected to rise significantly for the years to come.
The investigators hypothesize that combination therapy with intravitreal aflibercept and a new computer navigated photocoagulations system (Navilas®) leads to a decreased need for intravitreal injections.
Further, the investigators wish to identify retinal risk markers for DME treatment outcome to assist individualized treatment planning. The evaluation of the baseline level of macular ischemia as marker of successful treatment outcome is of particular interest as this is still highly debatable and may prove a significant prognostic factor of anatomical and functional outcome to anti-VEGF treatment.
The ADDENDUM study (four-year part-time PhD study) is a 12-month prospective randomized 1:1 study to compare intravitreal aflibercept and Navilas® laser (Group A) with intravitreal aflibercept and conventional Pascal laser (Group B) in the treatment of DME.
Eligibility criteria: DM, age 18-99, clinically significant macular edema, central retinal thickness > 300 μm, best corrected visual acuity 35-75 Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
The investigators believe that this study holds the potential to set precedent for a new gold standard of DME-treatment with increased treatment effect, reduced risks and a more cost-effective approach.
详细描述
Introduction:
Diabetic retinopathy (DR) is the most common complication among the 300,000 Danish patients with diabetes. Amongst those with diabetes, diabetic macular edema (DME) is a leading cause of visual impairment and will in time affect 29% of all patients.
It was established by the Early Treatment Diabetic Retinopathy Study (ETDRS) that focal/grid laser photocoagulation reduces the risk of visual loss in patients with DME but with a small likelihood of visual improvement. In recent years intravitreal anti-VEGF agents like bevacizumab, ranibizumab and aflibercept have consistently demonstrated efficacy and visual improvement in DME-treatment. However, a high number of injections is needed per patient to achieve sustainable visual improvement. Diabetic Retinopathy Clinical Research Network (DRCR.net) showed, that the median number of intravitreal ranibizumab injections was 9 in the first and 3 in the second year.
The burden of intravitreal injections is a concern and it is substantial both for patients as well as the health care system. Because of DME, 550 intravitreal injections were given at Odense University Hospital in 2014. The medicine expenses of this approximate 3.3 million DKK and with an increasing prevalence of diabetes the number is expected to rise significantly for the years to come.
This calls for initiatives like a more cost-effective treatment and a better understanding of underlying predictors of successful treatment in order to improve and individualize treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus
- •Clinically significant macular edema in the study eye.
- •Central retinal thickness > 300 μm in the study eye.
- •Best corrected visual acuity 35-80 ETDRS letters (0.10-0.80 Snellen equivalent) in the study eye.
排除标准
- •Pregnancy.
- •Active proliferative diabetic retinopathy in the study eye.
- •History of cataract surgery, YAG capsulotomy, vitrectomy or retinal laser treatment in the study eye within 4 months prior to randomization.
- •Ocular condition(s) in the study eye that in the opinion of the investigator would prevent improvement of visual acuity.
研究组 & 干预措施
Navigated laser
Aflibercept, Navilas®
干预措施: Navigated laser (Device)
Conventional laser
Aflibercept, Pascal
干预措施: Conventional laser (Device)
结局指标
主要结局
Percentage of eyes that received additional aflibercept injections after laser at month 12 in group A and B
时间窗: 1 year
次要结局
- Number of additional aflibercept injections after laser at month 12 in group A and B(1 year)
- Change in ETDRS visual acuity from baseline to month 12 in group A and B(1 year)
- Change in global retinal vessel geometric markers from baseline to month 12 in group A and B(1 year)
- Change in macular retinal vessel geometric markers from baseline to month 12 in group A and B(1 year)
- Change in global oxygen saturation from baseline to month 12 in group A and B(1 year)
- Change in macular oxygen saturation from baseline to month 12 in group A and B(1 year)
- Evaluation of non-invasive retinal risk factors (retinal vascular geometric markers and oxygen saturation) for successful treatment outcome at month 12(1 year)
- Change in level of macular ischemia (area of foveal avascular zone (FAZ)) from baseline to month 12 in group A and B(1 year)
- Evaluation of baseline area of foveal avascular zone (FAZ) as marker of successful treatment outcome at month 12(1 year)
研究者
Søren Leer Blindbæk
MD
Odense University Hospital