Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2)

Bayer

Status and phase: Completed; Phase 3

Conditions: Macular Degeneration

Treatments: Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321); Drug: Ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00637377

91689

2007-000583-25 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

Data of this trial ("VIEW 2") was pooled with data of a sister trial ("VIEW 1", NCT00509795), and an integrated analyses of the combined data was performed.

Enrollment: 1,240 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,240 participants in 4 patient groups

Ranibizumab 0.5mg Q4

Active Comparator group

Description:

Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Treatment:

Drug: Ranibizumab

Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4

Experimental group

Description:

Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Treatment:

Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4

Experimental group

Description:

Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Treatment:

Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8

Experimental group

Description:

Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

Treatment:

Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)