Femme et Homme
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Extrait
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.
Critère d'inclusion
- Diabetic Macular Edema (DME)