Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Intervention description: A dose of 2 mg aflibercept injected intravitreally
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 336.0
Sex: All
Minimum age: 51 Years
Healthy volunteers: No
Keywords: Age-related macular degeneration (AMD); Eylea treatment; Treat and Extend; Intravitreal

Summary:

      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)
    

Eligibility criteria:

        Inclusion Criteria:

          -  The following criteria must have been met at the initial start of aflibercept
             treatment (i.e. start of aflibercept treatment at least 1 year before this study):

               -  Subject had primary subfoveal choroidal neovascularization (CNV) lesions
                  secondary to nAMD, including juxtafoveal lesions that affect the fovea, as
                  evidenced by fluorescein angiography/photography (FA/FP) of the study eye within
                  3 weeks before the initiation of aflibercept treatment.

               -  The area of CNV occupied at least 50% of the total lesion within 3 weeks before
                  the initiation of aflibercept treatment.

               -  Documented best-corrected visual acuity (BCVA) was 20/40 to 20/320 (letter score
                  of 73 to 25) in the study eye at the initiation of treatment.

          -  Men and women >= 51 years of age

          -  The subject's history of aflibercept treatment meets ALL of the following:

               -  Treatment in the study eye was initiated with three monthly (-1 week/+2 weeks)
                  doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were
                  observed

               -  Following the above initiation phase, the intervals between treatments were
                  between 6 weeks and 12 weeks

        Exclusion Criteria:

        - Any prior or concomitant therapy with an investigational or approved agent to treat
        neovascular AMD in the study eye other than aflibercept.

          -  Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and
             neovascularization) as assessed by fluorescein angiography (FA) in the study eye

          -  Subretinal hemorrhage that was:

               1. 50% or more of the total lesion area, or

               2. if the blood was under the fovea, and

               3. the blood under the fovea was 1 or more disc areas in size in the study eye.

          -  Scar or fibrosis making up more than 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.

          -  Causes of CNV other than AMD in the study eye.