At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 333 enrolled
Drug / intervention
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) +1 moredrug
Likely dose
Not stated in 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, Double-masked, Sham-controlled Phase 3b/4 Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy as Indicated in Subjects With Polypoidal Choroidal Vasculopathy
In Brief
A Phase 4 clinical trial evaluating Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) and Visudyne for Neovascular Macular Degeneration. Completed, enrolled 333 participants across 62 sites in 8 countries.
Detailed Summary
To collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeovascular Macular Degeneration
CountriesAustralia, Germany, Hong Kong, Hungary, Japan, Singapore, South Korea, Taiwan
CollaboratorsRegeneron Pharmaceuticals
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartMay 2014
Primary CompletionAug 2016
Study CompletionJul 2017
TodayJul 2026
First PostedApr 23, 2014
Enrollment StartMay 29, 2014
Primary CompletionAug 12, 2016
Study CompletionJul 7, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.2 years ago
Interventions
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)drug
Eylea is administered as an intravitreal injection
Visudyneother
Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)