At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 243 enrolled
Drug / intervention
pegaptanib sodium +1 moredrug
Likely dose
pegaptanib sodium 0.3 mgfrom 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 3, Randomized, Controlled, Double-Masked, Multi-Center, Comparative, In Parallel Groups (For 24 Weeks), To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium, With Sham Injections, And Open Study (For 30 Weeks) To Confirm The Safety Of 0.3 MG Pegaptanib Sodium In Subjects With Diabetic Macular Edema (DME)
In Brief
A Phase 3 clinical trial evaluating pegaptanib sodium and sham injection for Macular Edema and 2 related conditions. Completed, enrolled 243 participants across 43 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Edema, Diabetic Mellitus, Retinal Disease
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartMay 2010
Primary CompletionAug 2012
TodayJul 2026
First PostedApr 8, 2010
Enrollment StartMay 1, 2010
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.2 years ago
Interventions
pegaptanib sodiumdrug
Intravitreal injection of 0.3 mg every 6 weeks
sham injectionother
sham injection every 6 weeks