Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye
Condition: Neovascular Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321); Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
Intervention description: Solution in Vial, intravitreal (IVT) injection; Solution in Vial, 2 mg, intravitreal (IVT) injection
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Up to Week 108: Participant and Investigator masked. Week 108 to Week 156: Participant and Investigator unmasked to treatment intervals.
Enrollment: 1011.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: nAMD

Summary:

      In this study researchers want to learn more about changes in visual acuity (clarity of
      vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from
      neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that
      causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood
      into the light sensitive lining inside the eye (retina). The fluid buildup causes the central
      part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken
      (edema), which distorts vision.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the
             fovea as assessed in the study eye.

          -  Total area of CNV (including both classic and occult components) must comprise greater
             than 50% of the total lesion area in the study eye.

          -  BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of
             approximately 20/32 to 20/320) in the study eye.

          -  Decrease in BCVA determined to be primarily the result of nAMD in the study eye.

          -  Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.

          -  Contraceptive use by men or women should be consistent with local regulations
             regarding the methods of highly effective contraception for those participating in
             clinical studies.

          -  Other protocol-specified inclusion criteria.

        Additional inclusion criteria for Year 3:

          -  At least one BCVA value and one central subfield retinal thickness (CST) value from
             measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or
             Visit 26 (Week 92).

          -  Participant is enrolled at a site that participates in the extension period.

        Exclusion Criteria:

          -  Causes of CNV other than nAMD in the study eye.

          -  Scar, fibrosis, or atrophy involving the central subfield in the study eye.

          -  Presence of retinal pigment epithelial tears or rips involving the central subfield in
             the study eye.

          -  Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma
             medication) in the study eye.

          -  History of idiopathic or autoimmune uveitis in the study eye.

          -  Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any
             refractive or cataract surgery.

          -  History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any
             retinal vascular disease other than nAMD in either eye.

          -  Evidence of extraocular or periocular infection or inflammation (including infectious
             blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of
             screening/randomization.

          -  Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg).

          -  Any prior or concomitant ocular (in the study eye) or systemic treatment (with an
             investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except
             dietary supplements or vitamins.

          -  Other protocol-specified exclusion criteria