At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 288 enrolled
Drug / intervention
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)drug
Likely dose
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) 2mgfrom 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 Randomized, Open-label Phase 4 Study Evaluating the Efficacy and Safety of Repeated Doses of Intravitreal Aflibercept With Variable Treatment Intervals in Japanese Subjects With Neovascular Age-related Macular Degeneration
In Brief
A Phase 4 clinical trial evaluating Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) for Wet Macular Degeneration. Completed, enrolled 288 participants across 41 sites.
Detailed Summary
To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet) Age-related Macular Degeneration (wAMD) . To assess the safety of IVT administration of aflibercept with two different approaches of Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWet Macular Degeneration
CountriesJapan
CollaboratorsRegeneron Pharmaceuticals
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartDec 2014
Primary CompletionDec 2016
Study CompletionDec 2017
TodayJul 2026
First PostedDec 2, 2014
Enrollment StartDec 19, 2014
Primary CompletionDec 22, 2016
Study CompletionDec 20, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.6 years ago
Interventions
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)drug
Aflibercept 2mg is intravitreally injected.