Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab (DORO)
Visual Acuity Reduced Transiently, Macular Edema, Cystoid
About this trial
This is an interventional treatment trial for Visual Acuity Reduced Transiently focused on measuring Diabetic Macular Edema, Ranibizumab, Visual Acuity, Diabetic Control
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Department of Ophthalmology, Charite, Berlin
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Regular Glycemic Control
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 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.
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.