Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 12 Baseline Visit
研究概览
简要总结
The aim of the prospective randomized study is to investigate whether a intensified diabetic control program leads to better final visual acuity and less frequent diabetic ocular complications in patients with diabetic retinopathy when compared with a normal diabetic treatment.
详细描述
Patients with diabetic macular edema (DME) will be treated with intravitreal ranibizumab injections and the effect of optimal control of internal factors (eg. glycemia, blood pressure etc) on final functional (best corrected visual acuity-CBVA) and morphological (central retinal thickness-CRT) will be investigated. Patients will be randomized into two groups: Group with intensified diabetic control will be follow and investigated monthly at department of diabetology, endocrinology and nutritional medicine (Campus Benjamin Franklin) in Berlin with aim to reach the optimal glycemic control defined as HbA1c < 6,5%. Further, triglycerides values < 140 mg/dl and blood pressure < 140/90 mmHg will be pursued. Second group of patients will be followed by their general practitioner and in the study center only blood samples will be taken quarterly without active medical intervention.
BCVA, CRT and the number of required ranibizumab injections will we evaluated and compared between both study groups.
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
- Single (Outcomes Assessor)
盲法说明
Observer-masking (assessment of BCVA, macular thickness, capillary drop-out) is done to guard against detection bias.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diabetic macular edema relevant to visual acuity
- •OCT central retinal thickness ≥ 250µm
- •HbA1c > 6,5% at initial visit
- •BCVA ≤0.8 and ≥0.05
- •Age ≥18 years
- •Written patient informed consent given
排除标准
- •Previous treatment with intravitreal drugs in last 6 months
- •Vitreous hemorrhage as a consequence of proliferative retinopathy
- •Pregnancy
- •Blood pressure of ≥ 180/100 (or uncontrolled pressures under pharmacological therapy)
- •Chronic systemic or ocular inflammatory/autoimmune diseases (e.g. inflammatory bowel disease, Addison´s disease, Cushing Syndrome, Uveitis)
- •Systemic cortisone or anti-VEGF therapy
- •Acute systemic or ocular infectious diseases
研究组 & 干预措施
Regular Glycemic Control
Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen. Patients randomized into this group will be controlled by their general practitioner or private diabetologist (usual care). The glycemic control (blood measurements of HbA1c) will be performed at trial site (Department of diabetology, endocrinology and nutritional medicine) every 3 months. The site will not influence or change the diabetes medication given by general physician and serves as an observer only to monitor the diabetic control.
干预措施: ranibizumab (Drug)
Intensified Glycemic Control
Diabetic macular edema will be treated with 3 monthly ranibizumab (0,5mg) injections followed by PRN regimen.
Patients randomized into this group will be controlled at the trial site (Department of diabetology, endocrinology and nutritional medicine) during first year monthly, in the second study year every 3 months. The individual HbA1c will be targeted according to the general status reflecting other risk factors for the vasculopathy (e.g. BMI, smoking, blood pressure, lipid status). All effort will be done to reach the target blood pressure ≤ 140/90 mmHg and blood triglyceride level < 140 mg/dl: Further the patients will be educated to improve their eating habits in regard to reduce the carbohydrate intake.
干预措施: ranibizumab (Drug)
结局指标
主要结局
Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 12 Baseline Visit
时间窗: Baseline to 12 months
Measured by the difference in ETDRS letters score between month 12 and baseline according to internal guideline of Charité department of ophthalmology.
次要结局
- Time to Reach Target HbA1c(24 months)
- Number of Treatments With Ranibizumab up to 6, 12, 18 and 24 Months of Treatment(Baseline to 12 months)
- Number of Panretinal Laser Photocoagulation (PRP) Treatments Necessary for Neovascular Complications(Baseline to 12 months)
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment(Baseline to 12 months)
- Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 6, 12, 24 and Baseline Visit(Baseline to 12 months)
- Macular Thickness Change at 6, 12, 18 and 24 Months Compared to Baseline(Baseline to 12 months)
- Number of Participants With Retinal Detachment, Central Retinal Artery Occlusion, or Endophthalmitis and/or Ocular Adverse Events That Are Related to Treatment(Baseline to 12 months)
研究者
Prof. Dr. Antonia M. Joussen
Prof. MD
Charite University, Berlin, Germany