NCT00320775

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	VEGF Trap	Part A: Six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. Part B: Up to 30 subjects will be randomly assigned in a 1:1 ratio to receive a single of 2.0 mg/eye VEGF Trap followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Part C: Approximately 30 subjects will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. After completion of Visit 8 (Day 57), patients from all parts of the study, may be eligible to continue in Open-label Extension and will receive 4.0 mg of VEGF Trap.

Timeline

• Start date: 2005-06-01
• Primary completion: 2008-06-01
• Completion: 2008-08-01
• First posted: 2006-05-03
• Last updated: 2015-03-18

Locations

8 sites across 1 country: United States