Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)

This is a double masked, prospective, randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal (IVT) injections of VEGF Trap into the study eye at 4- or 12 -week intervals over a 12-week period.

After Week 12, patients will be evaluated every 4 weeks. Patients will remain on study or may be eligible to enter a long-term extension study, in which they will continue to receive VEGF Trap.

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.