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Managing Neovascular (Known as "Wet") Age-related Macular Degeneration Over 2 Years Using Different Treatment Schedules of 2 mg Intravitreal Aflibercept Injected in the Eye

NCT02581891 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2023-11-08

Study results available
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Summary

This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.

Conditions

  • Macular Degeneration

Interventions

DRUG

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

3 monthly doses followed by individualized treatment intervals of between 8 to16 weeks based on protocol-defined anatomical criteria

DRUG

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

3 monthly doses followed by five 8-weekly doses (5 x 2Q8), then by individualized treatment intervals of between 8 to 16 weeks based on protocol-defined anatomical criteria

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-19
Primary Completion
2019-04-26
Completion
2019-04-26
FDA Drug
Yes

Countries

  • Australia
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT02581891 on ClinicalTrials.gov