At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 127 enrolled
Drug / intervention
aflibercept +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.
Randomized, Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
In Brief
A Phase 3 clinical trial evaluating aflibercept and laser photocoagulation for Retinopathy of Prematurity. Completed, enrolled 127 participants across 52 sites in 13 countries.
Detailed Summary
The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinopathy of Prematurity
CountriesBulgaria, Colombia, Czechia, Hungary, Romania, Russia, Slovakia, South Korea, Taiwan, Thailand, Turkey (Türkiye), United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartOct 2019
Primary CompletionAug 2022
TodayJul 2026
First PostedSep 24, 2019
Enrollment StartOct 30, 2019
Primary CompletionAug 18, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.8 years ago
Interventions
afliberceptdrug
Administered IVT
laser photocoagulationprocedure
Transpupillary conventional laser will be administered according to standard local procedures.