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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.

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

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Treatments: Aflibercept

Criteria

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