A randomized, double-masked, multicenter, phase II study assessing the safety and efficacy of two concentrations of ranibizumab (intravitreal injections) compared with non-treatment control for the tr...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-000487-11

A randomized, double-masked, multicenter, phase II study assessing the safety and efficacy of two concentrations of ranibizumab (intravitreal injections) compared with non-treatment control for the treatment of diabetic macular edema with center involvement

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Extrait

The primary objective is to explore whether the activity of ranibizumab (6 and/or 10 mg/ml) treatment is superior to sham treatment in reducing macular edema from baseline to Month 6 in patients diagnosed with DME with center involvement.


Critère d'inclusion

  • Male and female patients >18 years of age with either type 1 or type 2 diabetes mellitus with stable HbA1c levels between 6.5 and 10% and diabetic macular edema with center involvement in at least one eye