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

Sponsor
Bayer
Study ID
NCT02818998
Phase
PHASE3
Status
Completed

Conditions

  • Macular Edema

Eligibility Criteria

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

Interventions

Study Details

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)

Key Dates

Start date
Nov 16, 2016
Status verified
Jul 2020
Primary completion
Nov 13, 2018
Completion
Sep 24, 2019

Study Design

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

Arms

  • Experimental: Aflibercept 2 mg fixed
    Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
  • Experimental: Aflibercept 2 mg flexible
    Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 week
  • Experimental: Aflibercept 2 mg PRN
    Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)

Primary Outcome Measure

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52 [ Time Frame: From baseline to Week 52 ]

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