At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 317 enrolled
Drug / intervention
Standard of Care +1 moredrug
Likely dose
Macugen 0.3mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 With An Open-Label Macugen Year 3 Extension.
In Brief
A Phase 3 clinical trial evaluating Standard of Care and Macugen for Macular Edema Associated With Diabetes Mellitus. Completed, enrolled 317 participants across 73 sites in 18 countries.
Detailed Summary
The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Brazil, Canada, Colombia, Czechia, Denmark, France, Germany, Greece, India, Italy, Netherlands, Portugal, South Africa, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2005
First PostedJan 2008
Primary CompletionNov 2009
Study CompletionJul 2011
TodayJul 2026
First PostedJan 31, 2008
Enrollment StartSep 1, 2005
Primary CompletionNov 1, 2009
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 18.4 years ago
Interventions
Standard of Caredrug
Clinicians decision to use optional laser therapy.
Macugendrug
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.