CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 45 enrolled
Drug / intervention
Aflibercept Injection [Eylea]drug
Likely dose
Aflibercept Injection [Eylea] 2.0mgfrom 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.

Search/NCT04288232
NCT04288232Phase 3Completed
CompareCT.gov

A Multicenter, Open-label, Prospective, Interventional Study to Assess the Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients in Taiwan

Taipei Veterans General Hospital, Taiwan·interventional·Posted Feb 28, 2020·Updated Feb 28, 2020

In Brief

A Phase 3 clinical trial evaluating Aflibercept Injection [Eylea] for Center-involved Diabetic Macular Edema. Completed, enrolled 45 participants.

Detailed Summary

Phase IIIb, multicenter, open-label, prospective, interventional study to assess the potential benefit of Aflibercept treatment administered IVT at a dosage of 2 mg with five monthly loading doses and then treat and extend over 48 weeks, with the primary endpoint as BCVA assessed at Week 52.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCenter-involved Diabetic Macular Edema
Countries--
CollaboratorsKaohsiung Veterans General Hospital., National Taiwan University Hospital, Chang Gung Memorial Hospital

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 28, 2020
Enrollment StartAug 31, 2015
Primary CompletionNov 16, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.3 years ago

Interventions

Aflibercept Injection [Eylea]drug

Intravitreal aflibercept Injection 2.0mg/0.05 ml