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

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.

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