At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 113 enrolled
Drug / intervention
Eylea (Aflibercept, 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.
Open-label, Randomized, Two-Arm, Controlled Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal (IVT) Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity (ROP)
In Brief
A Phase 3 clinical trial evaluating Eylea (Aflibercept, BAY86-5321) and Laser photocoagulation for Retinopathy of Prematurity (ROP). Completed, enrolled 113 participants across 90 sites in 27 countries.
Detailed Summary
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinopathy of Prematurity (ROP)
CountriesArgentina, Austria, Belgium, Brazil, Bulgaria, Czechia, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
CollaboratorsRegeneron Pharmaceuticals
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartSep 2019
Primary CompletionFeb 2021
TodayJul 2026
First PostedJul 1, 2019
Enrollment StartSep 25, 2019
Primary CompletionFeb 12, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.0 years ago
Interventions
Eylea (Aflibercept, BAY86-5321)drug
Solution in a sterile glass vial, Dose A, IVT injection.
Laser photocoagulationprocedure
Transpupillary conventional laser ablative therapy