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A 24-month randomized, double-masked, multicenter, phase II study assessing safety and efficacy of verteporfin (Visudyne®) photodynamic therapy administered in conjunction with Lucentis™ versus Lucent...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-004172-12

A 24-month randomized, double-masked, multicenter, phase II study assessing safety and efficacy of verteporfin (Visudyne®) photodynamic therapy administered in conjunction with Lucentis™ versus Lucentis™ monotherapy in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

Femme et Homme

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Extrait

1. The main purpose of this amendment is to extend the study duration. Based upon feedback from Health Authorities in France, Sweden and USA the study is extended to allow collection of long term (2 years) safety data. In addition, collection of treatment pattern related data for up to 2 years would allow better differentiation between Visudyne and Lucentis combination arms and Lucentis monotherapy in terms of possibly reduced treatment burden. Study results may be used for label extension. 2.Correct data of the sponsor.

Critère d'inclusion

  • Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)

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