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Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients in Taiwan

NCT04288232 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-02-28

No results posted yet for this study

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.

Conditions

  • Center-involved Diabetic Macular Edema

Interventions

DRUG

Aflibercept Injection [Eylea]

Intravitreal aflibercept Injection 2.0mg/0.05 ml

Sponsors & Collaborators

  • Kaohsiung Veterans General Hospital.

    collaborator OTHER

  • National Taiwan University Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Principal Investigators

  • Shih-Jen Chen, MD, PhD · Department of Ophthalmology, Taipei Veterans General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-11-16
Completion
2017-11-16

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04288232 on ClinicalTrials.gov