Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab

Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab

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.

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.

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