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A 12-month, two-armed, randomized, double-masked, multicenter, Phase IIIb study assessing the efficacy and safety of laser photocoagulation as adjunctive to Ranibizumab intravitreal injections vs. las...

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-018852-29

A 12-month, two-armed, randomized, double-masked, multicenter, Phase IIIb study assessing the efficacy and safety of laser photocoagulation as adjunctive to Ranibizumab intravitreal injections vs. laser photocoagulation monotherapy in patients with visual impairment due to diabetic macular edema followed by a 12 month follow up period

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Extrait

The primary objective of this study is to demonstrate superiority of an adjunctive treatment of laser photocoagulation to Ranibizumab 0.5 mg as intravitreal injection in the mean change in BCVA from baseline to month 12 compared to laser monotherapy.

Critère d'inclusion

  • Diabetic macular edema

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