Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD

To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.

A double-masked study in which approximately 12 subjects will receive ITV injections of VEGF Trap every 4 weeks for a total of 3 doses. Once the subjects have received the 3 doses allowed in this study, they will be evaluated every 4 weeks for continued dosing of VEGF Trap for an additional 9 months.

• Drug: VEGF Trap
  VEGF Trap formulation 1, ITV-1
  Other Name: ITV-1
• Biological: VEGF Trap
  VEGF Trap formulation 2 at higher concentration in Open label cohort
  Other Name: ITV-2

• Experimental: ITV-1
  VEGF Trap formulation 1
  Intervention: Drug: VEGF Trap
• Experimental: ITV-2
  VEGF Trap formulation 2
  Intervention: Drug: VEGF Trap
• Experimental: ITV-2 OL
  VEGF Trap formulation 2 open label, higher concentration
  Intervention: Biological: VEGF Trap

Inclusion Criteria:

• Subfoveal CNV secondary to AMD.
• Central retinal (including lesion) thickness ≥ 250 µm as measured by OCT.
• ETDRS best-corrected visual acuity (BCVA) of 20/40 to 20/400 (73 to 20 letters)

Exclusion Criteria:

• No 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 (Visit 2);
  • PDT or ITV administration of triamcinolone acetonide or any other steroid within 12 weeks prior to Day 1 (Visit 2);
  • Pegaptanib sodium within 8 weeks of Day 1 (Visit 2);
  • Juxtascleral steroids or anecortave acetate within 180 Days (6 months) prior to Day 1 (visit 2);
  • Prior systemic or intravitreal treatment with VEGF Trap or bevacizumab;
  • Any investigational agent for the treatment of eye disease within 12 weeks of Day 1 (Visit 2)
• History of any vitreous hemorrhage within 4 weeks prior to baseline injection visit.
• Aphakia or pseudophakia with the absence of a posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] capsulotomy).
• Significant subfoveal atrophy or scarring.
• Any condition or laboratory abnormality that, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the subject's appropriate participation in this study