Safety and Tolerability Study of Intravitreal VEGF-Trap Administration in Patients With Neovascular AMD

An Exploratory Study of the Safety, Tolerability and Biological Effect of Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration

The purpose of this trial is to assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

This study consists of three parts, Part A, Part B and Part C. Part A is a dose escalation. Part B was terminated early. The (one) subject who received Macugen is not discussed in this website. Part C had subjects receive one of two doses of VEGF Trap (0.15 mg or 4.0 mg).

This is the first study in which human subjects received intravitreal injections of VEGF Trap in a study eye.

Inclusion Criteria:

• Subfoveal CNV secondary to AMD.

• Central retinal/lesion thickness ≥ 250µm as measured by optical coherence tomography (OCT).

• ETDRS best-corrected visual acuity of:

  • 20/40 (73 letters) or worse

• Clear ocular media and clear lens(es) to permit good quality stereoscopic fundus photography.

Exclusion Criteria:

• Prior treatment with VEGF Trap, bevacizumab or ranibizumab.
• Any investigational agent within 12 weeks of Visit 2 (Day 1).
• Presence of other causes of CNV.
• Active ocular infection.