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
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321); Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
Intervention description: 3 monthly doses followed by individualized treatment intervals of between 8 to16 weeks based on protocol-defined anatomical criteria; 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
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 287.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Neovascular age-related macular degeneration; nAMD)

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

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 50 years of age.

          -  Active primary subfoveal CNV lesions secondary to nAMD, including juxtafoveal lesions
             that affect the fovea as evidenced by FA in the study eye. Patients with polypoidal
             choroidal vasculopathy or retinal angiomatous proliferation are eligible to
             participate in the study, and their condition should be captured in the eCRF.

          -  ETDRS BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye.

          -  The area of CNV must occupy at least 50% of the total lesion.

        Exclusion Criteria:

          -  Any prior ocular (in the study eye) or systemic treatment or surgery for nAMD, except
             dietary supplements or vitamins.

          -  Any prior or concomitant therapy with another investigational agent to treat nAMD in
             the study eye.

          -  Prior treatment with anti-VEGF agents as follows:

          -  Prior treatment with anti-VEGF therapy in the study eye is not allowed

          -  Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent
             (not approved, e.g. bevacizumab) within the last 3 months before the first dose in the
             study. Such treatment will also not be allowed during the study. Prior treatment with
             an approved anti-VEGF therapy in the fellow eye is allowed.

          -  Prior systemic anti-VEGF therapy, investigational or approved, within the last 3
             months before the first dose in the study, and such treatment will not be allowed
             during the study.

          -  Total lesion size >12 disc areas (30.5 mm2, including blood, scars and
             neovascularization) as assessed by FA in the study eye.

          -  Subretinal hemorrhages that are either 50% or more of the total lesion area, or if the
             blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the
             blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible
             CNV).

          -  Scar or fibrosis making up >50% of the total lesion in the study eye.

          -  Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.

          -  Presence of retinal pigment epithelial tears or rips involving the macula in the study
             eye.