A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema

Summary

The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.

Timeline

Start

2010-05

Primary completion

2012-08

Completion

2012-08

Outcome

Met primary endpoint

registry Pegaptanib Sodium vs Sham in Double Masked, Then Pegaptanib Sodium in Open Phase; p = 0.0003; Odds Ratio (OR) 4.85 (95% CI 1.92 to 12.28) NCT01100307 ↗

Drugs

Indications