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A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreous Injections of 0.3 mg Pegaptanib Sodium (Macu...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-001460-32

A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreous Injections of 0.3 mg Pegaptanib Sodium (Macugen), Given as Often as Every 6 Weeks for 2 years, to Sham Injections, in Subjects with Diabetic Macular Edema (DME) Involving the Center of the Macula

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Extrait

The objective of this trial will be to confirm the safety and compare the efficacy of pegaptanib sodium when subjects are given intravitreous injections of 0.3 mg/eye versus sham injections in a 1:1 ratio, respectively. All subjects previously randomized to the 0.03 or 0.003 mg/eye treatment arms during the conduct of EOP1013 through EOP1013C will be given the option of either receiving injections of 0.3 mg/eye or withdrawing from the study. Injections will be given as often as every 6 weeks for 2 years, in subjects with diabetic macular edema (DME) involving the center of the macula associated with vision loss not due to ischemia.

Critère d'inclusion

  • Diabetic Macular Edema (DME)

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