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

Phase 3

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: Ranibizumab; Biological: Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT00637377
• Lead Sponsor: Bayer

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-17
• Study First Posted: 2008-03-18
• Study Start: 2008-04
• Primary Completion: 2010-09
• Study Completion: 2011-08
• Results First Submitted: 2011-12-16
• Results First Submitted QC: 2011-12-16
• Results First Posted: 2012-01-23
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-28
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1240

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab 0.5mg Q4	Ranibizumab	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.
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4	Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	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.
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4	Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	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.
Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8	Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)	At week 52	Maintenance of vision was defined as a loss of \< 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.; Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF	Baseline and at week 52	Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF	At week 52	Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.; Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed.
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF	Baseline and at week 52	CNV area values measured in square millimeters; lower values represent better outcomes.
Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF	Baseline and at week 52	The possible range of the NEI VFQ-25 total score is between 0 (worst possible) and 100 (best possible).