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Efficacy and Safety of Three Different Aflibercept Regimens in Subjects With Diabetic Macular Edema (DME)

NCT02818998 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2020-07-31

Study results available
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Summary

To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment)

Conditions

  • Macular Edema

Interventions

DRUG

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-16
Primary Completion
2018-11-13
Completion
2019-09-24

Countries

  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Companies

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 NCT02818998 on ClinicalTrials.gov