VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into the eye administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual function in Chinese subjects with age-related neovascular or "wet" age-related macular degeneration.

Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both treatment groups will receive the other treatment as a sham procedure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Signed and dated informed consent form

• Men and women ≥ 50 years of age.

• Active predominantly classic subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD (wet Age-Related Macular Degeneration)

• BCVA (best corrected visual acuity) of 20/40 to 20/320 in the study eye

Exclusion Criteria:

• Only one functional eye

• Presence of CNV with an origin other than wAMD

• Any prior ocular or systemic treatment or surgery for wAMD, except dietary supplements or vitamins