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

Sponsor
Bayer
Study ID
NCT02581891
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Nov 19, 2015
Status verified
Nov 2023
Primary completion
Apr 26, 2019
Completion
Apr 26, 2019

Study Design

Enrollment
287 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Early-start T&E / Arm 1
    Early-start T\&E arm: test group, early treatment individualization
  • Active Comparator: Late-start T&E / Arm 2
    Late-start T\&E arm; per label, control group, treatment individualization after Year 1

Primary Outcome Measure

Change in BCVA as Measured by the ETDRS Letter Score [ Time Frame: From Week 16 to Week 104 ]

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