At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 131 enrolled
Drug / intervention
pegaptanib sodium injectiondrug
Likely dose
pegaptanib sodium injection 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 IV, Open Label, Multi-center Study to Assess the Effect of Intravitreal Injections of Macugen (Pegaptanib Sodium Injection) Administered Every 6 Weeks for 48 Weeks on the Corneal Endothelium.
In Brief
A Phase 4 clinical trial evaluating pegaptanib sodium injection for Age-Related Macular Degeneration and 2 related conditions. Completed, enrolled 131 participants across 4 sites.
Detailed Summary
This study was conducted because the FDA requested clinical information on potential effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal endothelium from a 1-year (minimum) post-approval clinical study to support that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2010
First PostedApr 2012
Primary CompletionNov 2019
TodayJul 2026
First PostedApr 9, 2012
Enrollment StartApr 22, 2010
Primary CompletionNov 14, 2019
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 14.2 years ago
Interventions
pegaptanib sodium injectiondrug
0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks