Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: aflibercept injection (VEGF Trap-Eye, BAY86-5321); aflibercept injection (VEGF Trap-Eye, BAY86-5321); 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 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12; Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.; Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12; Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.; Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 159.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Neovascular Age-Related Macular Degeneration

Summary:

      This study examines the effect of intravitreally administered VEGF Trap in patients with wet
      AMD.

      The purpose of this trial is to assess the ocular and systemic safety and tolerability of
      repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal
      neovascularization (CNV) due to AMD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subfoveal CNV secondary to AMD.

          -  Central retinal (including lesion) thickness ≥ 300 µm as measured by Optical Coherence
             Tomography (OCT).

          -  Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of
             73 letters to 34 letters.

        Exclusion Criteria:

          -  History of any vitreous hemorrhage within 4 weeks prior to Day 1.

          -  Aphakia.

          -  Significant subfoveal atrophy or scarring.

          -  Prior treatment with the following in the study eye:

               -  Subfoveal thermal laser therapy.

               -  Submacular surgery or other surgical intervention for the treatment of AMD.

               -  Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1.

               -  Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1).

               -  Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1).

               -  Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to
                  Visit 2 (Day 1).

               -  Intravitreal administration of triamcinolone acetonide or other steroids within
                  24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance
                  can be seen in the vitreous cavity using indirect ophthalmoscopy.

               -  Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis)
                  or bevacizumab (Avastin).

          -  Presence of any other condition or laboratory abnormality, which, in the opinion of
             the Investigator, would interfere with the assessment of disease status/progression or
             jeopardize the patient's appropriate participation in this Phase II study.