A 2 year randomized, single-masked, multicenter, controlled phase IIIb trial assessing the Efficacy and safety of 0.5 mg ranibizumab in two “treat and extend” treatment algorithms vs. 0.5 mg ranibizum...

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Reference: EUCTR2010-019795-74

A 2 year randomized, single-masked, multicenter, controlled phase IIIb trial assessing the Efficacy and safety of 0.5 mg ranibizumab in two “treat and extend” treatment algorithms vs. 0.5 mg ranibizumab as needed in patients with macular edema and visual Impairment secondary to diabetes mellitus

Woman and Man

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Extract

To demonstrate that the mean change from baseline in Best Corrected Visual Acuity (BCVA) over a 12 month treatment period obtained with either a 0.5 mg ranibizumab “Treat and Extend” (TE) dosing regimen with adjunctive laser, and/or with 0.5 mg ranibizumab TE dosing regimen alone is at least non-inferior to 0.5 mg ranibizumab alone given PRN in patients with visual impairment due to DME to cover a potential superiority claim. The condition for the interpretation of these results is the assessment of the extent to which the TE dosing regimens could be maintained during the study duration.


Inclusion criteria

  • Diabetic Macular Edema (DME)