Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)
Condition: Age - Related Macular Degeneration (AMD)
MeSH terms: Macular Degeneration
Intervention: Intravitreal Aflibercept Injection (IAI)
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD

Summary:

      This is a phase 4, open-label, single arm, multicenter, clinical study in patients with
      neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept
      Injection (IAI) administered over 2 years , and to provide clinical information from the
      first year in the trial evaluating the adverse effects, if any, on the corneal endothelium
      following administration of IAI.
    

Eligibility criteria:

        Inclusion criteria include but are not limited to:

          1. Men or women great than or equal to 50 years of age with unilateral neovascular AMD

          2. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye

          3. Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD,
             including juxtafoveal lesions that affect the fovea as evidenced by FA in the study
             eye

          4. The CNV area must be at least 50% of total lesion size

          5. Willing and able to comply with clinic visits and study-related procedures

          6. Provide signed informed consent

          7. Provide signed Health Insurance Portability and Accountability Act (HIPAA)
             authorization

        Exclusion criteria include but are not limited to:

          1. Neovascular AMD in the fellow eye

          2. Corneal endothelial measures as judged by an independent reading center

          3. Any prior use of intraocular anti-VEGF treatment for neovascular AMD in either eye

          4. Structural damage to the center of the macula in the study eye that is likely to
             preclude improvement in BCVA following the resolution of macular edema

          5. History of cataract surgery, or other intraocular surgery in either eye, within 1 year
             of screening

          6. History of cataract surgery, or other intraocular surgery in either eye, within 1 year
             of screening, or yttrium aluminum garnet (YAG) Capsulotomy within 3 months of
             screening

          7. Contact lens wear in either eye within 6 months of screening

          8. History of angle closure glaucoma in either eye

          9. Intraocular laser therapy including selective laser trabeculoplasty (SLT), YAG,
             prophylactic peripheral iridotomy (PI) in either eye within 1 year of screening, or
             YAG Capsulotomy within 3 months of screening

         10. History of cataract surgery requiring an anterior chamber intraocular lens implant at
             any time in either eye

         11. Any prior ocular trauma (blunt or penetrating) in either eye

         12. Embedded corneal foreign body in either eye

         13. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either
             eye

         14. Ocular media of insufficient quality to obtain fundus and OCT images in the study eye

         15. Any prior ocular inflammation/infection in either eye within 3 months of the screening
             visit

         16. Any prior use of amantadine

         17. Significant pre-retinal fibrosis involving the macula in the study eye (where, in the
             opinion of the investigator, the pre-retinal fibrosis is causing distortion or
             traction on the central macular region which may be limiting vision, or inducing
             retinal edema/thickening, beyond that due to underlying CNV)

         18. Intraocular pressure (IOP) greater than or equal to 30 mm Hg in the study eye at
             screening

         19. Uncontrolled diabetes mellitus (DM) (HbA1c ≥8)

         20. Current treatment with systemic anti-VEGF therapeutics at screening

         21. Known serious allergy to the fluorescein sodium for injection in angiography

         22. Participation in an investigational study within 30 days prior to the screening visit
             that involved treatment with any drug (excluding vitamins and minerals) or device.

         23. Positive serum hCG pregnancy test at the screening visit