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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Bayer
• Treatments: Aflibercept

Criteria

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.