Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

Sponsor
Bayer
Study ID
NCT02540954
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)

Key Dates

Start date
Sep 29, 2015
Status verified
Jun 2021
Primary completion
Dec 24, 2019
Completion
Jun 4, 2020

Study Design

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

Arms

  • Experimental: Aflibercept extended dosing
    Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
  • Active Comparator: Aflibercept 2Q8 (2 mg aflibercept administered every 8 weeks)
    Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.

Primary Outcome Measure

Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye [ Time Frame: From baseline to Week 52 ]

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