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

Completed · Phase 3 · Has a placebo group

Conditions studied: Macular Degeneration

In brief

This study is a phase 3, 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 the US and Canada.

Key facts

Study ID

NCT00509795

Run by

Regeneron Pharmaceuticals

People needed

1217

Starts

2007-08-01

Expected to finish

2011-07-01

Last updated by the study team

2012-12-28

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 FA in the study eye.
• Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) of: letter score of 73 to 25 (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. See Appendix J.4) understand and willing to sign the informed consent form.
• Key

You may not qualify if…

• 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, except dietary supplements or vitamins.
• Any prior treatment with anti-VEGF agents in the study eye.
• Total lesion size > 12 disc areas (30.5 mm\^2, including blood, scars and neovascularization) as assessed by FA in the study eye.
• Subretinal hemorrhage 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 270 degrees by visible CNV.)
• Scar or fibrosis, making up > 50% of total lesion in the study eye.
• Scar, fibrosis, or atrophy involving the center of the fovea.
• 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.
• History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina,other than AMD, in either 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 its unlikely to interfere with the injection.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Campbell, California, United States
• Study site — Fullerton, California, United States
• Study site — Glendale, California, United States
• Study site — Irvine, California, United States
• Study site — La Jolla, California, United States
• Study site — Loma Linda, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Menlo Park, California, United States
• Study site — Mountain View, California, United States
• Study site — Oakland, California, United States
• Study site — Palm Springs, California, United States
• Study site — Pasadena, California, United States
• Study site — Poway, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Ana, California, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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