Ranibizumab "Treat and Extend" in Diabetic Macular Edma (OPTIMAL)
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This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.
An Open-label, Prospective, Multicentre, Uncontrolled, Proof of Concept Study Assessing the Efficacy of Lucentis (Ranibizumab) Administered by an Individualized "Treat and Extend" Dosing Regimen in Patients With Visual Impairment Due to Diabetic Macular Edema
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 18 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Visual impairment due to focal or diffuse macular edema with center involvement
Diabetes type 1 or 2, HbA1c < 12.0%
CRT = or > 250 μm
Active inflammation or infection
Iris neovascularization, active proliferative retinopathy or vitreomacular traction
Prior laser photocoagulation according to defined timelines
History of stroke, uncontrolled hypertension
Other protocol-defined inclusion/exclusion criteria may apply