VIEW 1 Study Seeking Participants

A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration

If you have recently been diagnosed with wet Age-Related Macular Degeneration (AMD), please consider joining the VIEW 1 study.

Doctors are currently looking for adults who have been recently diagnosed with wet AMD to participate in a medical research study. This study will evaluate the safety and effectiveness of an investigational medication to see if it helps slow or stop the progression of wet AMD-related vision loss.

Qualified participants will receive study related medical evaluations and study medication at no cost.

Study Sponsor: Regeneron Pharmaceuticals

To locate a study site near you, please choose one of the following options:

• Call 866-549-VIEW (8439)
• Email
• Go to View 1 Study at ClinicalTrials.gov. This link will open in a new browser window.

Key Inclusion Criteria:

1. Signed Informed Consent.
2. Men and women 50 years of age and older.
3. Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
4. CNV must be at least 50% of total lesion size.
5. ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
6. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
7. 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 Exclusion Criteria:

1. Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.
2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.
3. Prior treatment with anti-VEGF agents as follows:
   • Prior treatment with anti-VEGF therapy in the study eye is not allowed.
   • Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent (not FDA approved, e.g. bevacizumab) is allowed up to 3 months prior to first dose in the study, and such treatment will not be allowed during the study. Prior treatment with an FDA/Health Canada approved anti-VEGF therapy in the fellow eye is allowed.
   • Prior systemic anti-VEGF therapy, investigational or FDA/Health Canada approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study
4. Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye.
5. 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.)
6. Scar or fibrosis, making up > 50% of total lesion in the study eye.
7. Scar, fibrosis, or atrophy involving the center of the fovea.
8. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
9. History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
10. Presence of other causes of CNV, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye.
11. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.
12. Prior vitrectomy in the study eye.
13. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
14. Any history of macular hole of stage 2 and above in the study eye.
15. 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.

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