Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Ranibizumab; Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321); Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321); Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
Intervention description: Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.; Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.; Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.; Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.
Intervention MeSH terms: Ranibizumab; Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1240.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Eye diseases; Vision Impairment and Blindness; Eyes and Vision; Seniors; Neovascular Age-Related Macular Degeneration (AMD); Retinal Disease

Summary:

      This study is a phase III, double-masked, randomized, study of the efficacy and safety of
      VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately
      1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent.

          -  Men and women >/=50 years of age.

          -  Active primary or recurrent subfoveal CNV lesions secondary to AMD, including
             juxtafoveal lesions that affect the fovea as evidenced by Fluorescein angiography (FA)
             in the study eye.

          -  ETDRS Best-Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to
             20/320) in the study eye at 4 meters.

          -  Willing, committed, and able to return for ALL clinic visits and complete all
             study-related procedures.

          -  Able to read, (or, if unable to read due to visual impairment, be read to verbatim by
             the person administering the informed consent or a family member) understand and
             willing to sign the informed consent form.

        Exclusion Criteria:

          -  Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular
             AMD, except dietary supplements or vitamins.

          -  Any prior or concomitant therapy with another investigational agent to treat
             neovascular AMD in the study eye.

          -  Any prior treatment with anti-VEGF agents in the study eye.

          -  Total lesion size >12 disc areas (30.5 mm, including blood, scars and
             neovascularization) as assessed by FA in the study eye.

          -  Subretinal hemorrhages that is 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.

          -  History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.

          -  Presence of other causes of CNV in the study eye.

          -  Prior vitrectomy in the study eye.

          -  History of retinal detachment or treatment or surgery for retinal detachment in the
             study eye.

          -  Any history of macular hole of stage 2 and above in the study eye.

          -  Any intraocular or periocular surgery within 3 months of Day 1 on the study eye,
             except lid surgery, which may not have taken place within 1 month of Day 1, as long as
             it is unlikely to interfere with the injection.

          -  History or clinical evidence of diabetic retinopathy, diabetic macular edema or any
             retinal vascular disease other than AMD in either eye.