Macular Edema, Cystoid Clinical Trial
Official title:
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.
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