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 (VEGF Trap-Eye, BAY86-5321); aflibercept injection (VEGF Trap-Eye, BAY86-5321); aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Intervention description: Participants received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection 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 2.0mg dose of aflibercept injection 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 0.5mg dose of aflibercept injection 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 2.0mg dose of aflibercept injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. 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: 1217.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study is a phase 3, 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 the US and Canada.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed Informed Consent.

          2. Men and women ≥ 50 years of age.

          3. Active primary or recurrent subfoveal CNV lesions secondary to AMD, including
             juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.

          4. Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
             of: letter score of 73 to 25 (20/40 to 20/320) in the study eye at 4 meters.

          5. Willing, committed, and able to return for ALL clinic visits and complete all
             study-related procedures.

          6. 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. See Appendix J.4)
             understand and willing to sign the informed consent form.

        Key

        Exclusion Criteria:

          1. Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular
             AMD except dietary supplements or vitamins.

          2. Any prior or concomitant therapy with another investigational agent to treat
             neovascular AMD in the study eye, except dietary supplements or vitamins.

          3. Any prior treatment with anti-VEGF agents in the study eye.

          4. Total lesion size > 12 disc areas (30.5 mm^2, including blood, scars and
             neovascularization) as assessed by FA in the study eye.

          5. Subretinal hemorrhage 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 270 degrees by visible
             CNV.)

          6. Scar or fibrosis, making up > 50% of total lesion in the study eye.

          7. Scar, fibrosis, or atrophy involving the center of the fovea.

          8. Presence of retinal pigment epithelial tears or rips involving the macula in the study
             eye.

          9. History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.

         10. Presence of other causes of CNV in the study eye.

         11. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any
             other vascular disease affecting the retina,other than AMD, in either eye.

         12. Prior vitrectomy in the study eye.

         13. History of retinal detachment or treatment or surgery for retinal detachment in the
             study eye.

         14. Any history of macular hole of stage 2 and above in the study eye.

         15. 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
             its unlikely to interfere with the injection.