Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD) (VIEW1)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Macular Degeneration

Treatments: Biological: ranibizumab; Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00509795

VGFT-OD-0605

Details and patient eligibility

About

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.

Enrollment: 1,217 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed Informed Consent.
2. Men and women ≥ 50 years of age.
3. 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.
4. 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.
5. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
6. 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. Any prior treatment with anti-VEGF agents in the study eye.
4. Total lesion size > 12 disc areas (30.5 mm^2, 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,217 participants in 4 patient groups

ranibizumab 0.5mg Q4

Active Comparator group

Treatment:

Biological: ranibizumab

aflibercept injection 2.0mg Q4

Experimental group

Treatment:

Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

aflibercept injection 0.5mg Q4

Experimental group

Treatment:

Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

aflibercept injection 2.0mg Q8

Experimental group

Treatment:

Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)