Overview

Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)

Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
Summary
This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Collaborator:
Regeneron Pharmaceuticals
Treatments:
Aflibercept
Endothelial Growth Factors
Ranibizumab
Criteria
Inclusion Criteria:

- Signed informed consent.

- Men and women >/=50 years of age.

- Active primary or recurrent subfoveal CNV lesions secondary to AMD, including
juxtafoveal lesions that affect the fovea as evidenced by Fluorescein angiography (FA)
in the study eye.

- ETDRS Best-Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to
20/320) in the study eye at 4 meters.

- Willing, committed, and able to return for ALL clinic visits and complete all
study-related procedures.

- Able to read, (or, if unable to read due to visual impairment, be read to verbatim by
the person administering the informed consent or a family member) understand and
willing to sign the informed consent form.

Exclusion Criteria:

- Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular
AMD, except dietary supplements or vitamins.

- Any prior or concomitant therapy with another investigational agent to treat
neovascular AMD in the study eye.

- Any prior treatment with anti-VEGF agents in the study eye.

- Total lesion size >12 disc areas (30.5 mm, including blood, scars and
neovascularization) as assessed by FA in the study eye.

- Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the
blood is under the fovea and is 1 or more disc areas in size in the study eye (if the
blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible
CNV).

- Scar or fibrosis making up >50% of the total lesion in the study eye.

- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.

- Presence of retinal pigment epithelial tears or rips involving the macula in the study
eye.

- History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.

- Presence of other causes of CNV in the study eye.

- Prior vitrectomy in the study eye.

- History of retinal detachment or treatment or surgery for retinal detachment in the
study eye.

- Any history of macular hole of stage 2 and above in the study eye.

- Any intraocular or periocular surgery within 3 months of Day 1 on the study eye,
except lid surgery, which may not have taken place within 1 month of Day 1, as long as
it is unlikely to interfere with the injection.

- History or clinical evidence of diabetic retinopathy, diabetic macular edema or any
retinal vascular disease other than AMD in either eye.