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

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

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.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration
• Intervention / Treatment: Biological: ranibizumab; Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321); Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321); Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

• Study Type: Interventional
• Enrollment (Actual): 1217
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3E 7MB
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 3N9
    • Victoria, British Columbia, Canada, V8V 1B3
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
  • Ontario
    • London, Ontario, Canada, N6A 4G5
    • Mississauga, Ontario, Canada, L4W 1W9
    • Ottawa, Ontario, Canada, K1H8L6
    • Toronto, Ontario, Canada, M5C 2T2
    • Toronto, Ontario, Canada, M4N3M5
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
    • Montreal, Quebec, Canada, H3A 1A1
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 1A5
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
    • Birmingham, Alabama, United States, 35223
  • Arizona
    • Phoenix, Arizona, United States, 85020
    • Phoenix, Arizona, United States, 85014
    • Tucson, Arizona, United States, 85704
    • Tucson, Arizona, United States, 85710
  • California
    • Beverly Hills, California, United States, 90211
    • Campbell, California, United States, 95008
    • Fullerton, California, United States, 92835
    • Glendale, California, United States, 91203
    • Irvine, California, United States, 92697
    • La Jolla, California, United States, 92037
    • Loma Linda, California, United States, 92354
    • Los Angeles, California, United States, 90048
    • Los Angeles, California, United States, 90033
    • Menlo Park, California, United States, 94025
    • Mountain View, California, United States, 94040
    • Oakland, California, United States, 94609
    • Palm Springs, California, United States, 92262
    • Pasadena, California, United States, 91105
    • Poway, California, United States, 92064
    • Sacramento, California, United States, 95819
    • San Diego, California, United States, 92120
    • San Francisco, California, United States, 94107
    • Santa Ana, California, United States, 92705
    • Torrance, California, United States, 90503
    • Ventura, California, United States, 93003
    • Westlake Village, California, United States, 91361
    • Yorba Linda, California, United States, 92887
  • Colorado
    • Aurora, Colorado, United States, 80045
    • Denver, Colorado, United States, 80230
    • Denver, Colorado, United States, 80205
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
    • Hamden, Connecticut, United States, 06518
    • New Haven, Connecticut, United States, 06510
    • New London, Connecticut, United States, 06320
  • Florida
    • Altamonte Springs, Florida, United States, 32701
    • Boynton Beach, Florida, United States, 33426
    • Fort Myers, Florida, United States, 33907
    • Ft. Lauderdale, Florida, United States, 33351
    • Ft. Myers, Florida, United States, 33912
    • Gainesville, Florida, United States, 32610
    • Jacksonville, Florida, United States, 32224
    • Miami, Florida, United States, 33136
    • Miami, Florida, United States, 33143
    • Mount Dora, Florida, United States, 32757
    • Orlando, Florida, United States, 32806
    • Orlando, Florida, United States, 32803
    • Oscala, Florida, United States, 34472
    • Palm Beach Gardens, Florida, United States, 33410
    • Pensacola, Florida, United States, 32503
    • Sarasota, Florida, United States
    • Stuart, Florida, United States, 34994
    • Tampa, Florida, United States, 33612
    • Winter Haven, Florida, United States, 33880
  • Georgia
    • Augusta, Georgia, United States, 30909
  • Hawaii
    • Aiea, Hawaii, United States, 96701
    • Honolulu, Hawaii, United States, 96813
  • Illinois
    • Oak Brook, Illinois, United States, 60523
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
    • Indianapolis, Indiana, United States, 46260
    • Indianapolis, Indiana, United States, 46202
    • Indianapolis, Indiana, United States, 46280
    • New Albany, Indiana, United States, 47150
  • Iowa
    • Iowa City, Iowa, United States, 52242-1091
  • Kansas
    • Wichita, Kansas, United States, 67214
  • Kentucky
    • Louisville, Kentucky, United States, 40202
    • Louisville, Kentucky, United States, 40207
    • Paducah, Kentucky, United States, 42001
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
    • New Orleans, Louisiana, United States, 70115
    • Shreveport, Louisiana, United States, 71105
  • Maine
    • Bangor, Maine, United States, 04401
    • Portland, Maine, United States, 04102
  • Maryland
    • Baltimore, Maryland, United States, 21287
    • Baltimore, Maryland, United States, 21209
    • Chevy Chase, Maryland, United States, 20815
    • Hagerstown, Maryland, United States, 21740
    • Towson, Maryland, United States, 21204
  • Massachusetts
    • Boston, Massachusetts, United States
    • Boston, Massachusetts, United States, 02215
    • Boston, Massachusetts, United States, 02111
    • Boston, Massachusetts, United States, 02114
    • Peabody, Massachusetts, United States, 01960
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
    • Battle Creek, Michigan, United States, 49015
    • Detroit, Michigan, United States, 48202
    • Grand Rapids, Michigan, United States, 49525
    • Jackson, Michigan, United States, 49201
    • Royal Oak, Michigan, United States, 48073
    • Southfield, Michigan, United States, 48034
    • West Bloomfield, Michigan, United States, 48322
  • Minnesota
    • Edina, Minnesota, United States, 55435
    • Minneapolis, Minnesota, United States, 55404
    • Rochester, Minnesota, United States, 55905
  • Missouri
    • Florissant, Missouri, United States, 63031
    • Kansas City, Missouri, United States, 64111
    • Kansas City, Missouri, United States, 64108
    • Springfield, Missouri, United States, 65804
    • St. Louis, Missouri, United States, 63110
  • Montana
    • Missoula, Montana, United States, 59801
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
    • Omaha, Nebraska, United States, 68131
  • Nevada
    • Las Vegas, Nevada, United States, 89144
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
    • New Brunswick, New Jersey, United States, 08901
    • Northfield, New Jersey, United States, 08225
    • Teaneck, New Jersey, United States, 07666
    • Toms River, New Jersey, United States, 08753
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
  • New York
    • Albany, New York, United States, 12206
    • Brooklyn, New York, United States, 11223
    • Lynbrook, New York, United States, 11563
    • New York, New York, United States, 10032
    • New York, New York, United States, 10021
    • New York, New York, United States, 10003
    • Poughkeepsie, New York, United States, 12601
    • Rochester, New York, United States, 14642
    • Rochester, New York, United States, 14620
    • Slingerlands, New York, United States, 12159
    • Syracuse, New York, United States, 13224
  • North Carolina
    • Asheville, North Carolina, United States, 28803
    • Charlotte, North Carolina, United States, 28210
    • Raleigh, North Carolina, United States, 27607
    • Southern Pines, North Carolina, United States, 28387
    • Winston-Salem, North Carolina, United States, 27157
  • Ohio
    • Cincinnati, Ohio, United States, 45242
    • Cincinnati, Ohio, United States, 45202
    • Columbus, Ohio, United States, 43215
    • Toledo, Ohio, United States, 43608
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
  • Oregon
    • Ashland, Oregon, United States, 97520
    • Portland, Oregon, United States, 97210
    • Portland, Oregon, United States, 97227
    • Salem, Oregon, United States, 97302
  • Pennsylvania
    • Kingston, Pennsylvania, United States, 18704
    • Philadelphia, Pennsylvania, United States, 19104
    • Philadelphia, Pennsylvania, United States, 19107
    • Philadelphia, Pennsylvania, United States, 19124
    • Pittsberg, Pennsylvania, United States, 15231
    • Pittsburgh, Pennsylvania, United States, 15212
    • Pittsburgh, Pennsylvania, United States, 15213
    • West Mifflin, Pennsylvania, United States, 15122
    • Wyomissing, Pennsylvania, United States, 19610
  • Rhode Island
    • Providence, Rhode Island, United States, 02903-4928
  • South Carolina
    • Charleston, South Carolina, United States, 29414
    • Columbia, South Carolina, United States, 29223
    • Greenville, South Carolina, United States, 29605
    • West Columbia, South Carolina, United States, 29169
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
  • Tennessee
    • Memphis, Tennessee, United States, 38119
    • Memphis, Tennessee, United States, 38120
    • Nashville, Tennessee, United States, 37203
  • Texas
    • Abilene, Texas, United States, 79606
    • Austin, Texas, United States, 78705
    • Corpus Cristi, Texas, United States, 78413
    • Dallas, Texas, United States, 75390
    • DeSoto, Texas, United States, 75115
    • Ft. Worth, Texas, United States, 76104
    • Ft. Worth, Texas, United States, 76102
    • Galveston, Texas, United States, 77555
    • Houston, Texas, United States, 77030
    • McAllen, Texas, United States, 78503
    • Odessa, Texas, United States, 79761
    • San Antonio, Texas, United States, 78240
  • Utah
    • Salt Lake City, Utah, United States, 84132
    • Salt Lake City, Utah, United States, 84107
  • Vermont
    • Burlington, Vermont, United States, 05401
  • Virginia
    • Charlottesville, Virginia, United States, 22908
    • Fairfax, Virginia, United States, 22031
    • Richmond, Virginia, United States, 23221
  • Washington
    • Seattle, Washington, United States, 98104
    • Silverdale, Washington, United States, 98383
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
    • Madison, Wisconsin, United States, 58705
    • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ranibizumab 0.5mg Q4	Biological: ranibizumab; Participants received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection 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.; Other Names: Lucentis
Experimental: aflibercept injection 2.0mg Q4	Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321); Participants received a 2.0mg dose of aflibercept injection 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.; Other Names: BAY86-5321; VEGF Trap-Eye; Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321); Participants received a 0.5mg dose of aflibercept injection 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.; Other Names: BAY86-5321; VEGF Trap-Eye; Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321); Participants received a 2.0mg dose of aflibercept injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.; Other Names: BAY86-5321; VEGF Trap-Eye
Experimental: aflibercept injection 0.5mg Q4	Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321); Participants received a 2.0mg dose of aflibercept injection 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.; Other Names: BAY86-5321; VEGF Trap-Eye; Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321); Participants received a 0.5mg dose of aflibercept injection 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.; Other Names: BAY86-5321; VEGF Trap-Eye; Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321); Participants received a 2.0mg dose of aflibercept injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.; Other Names: BAY86-5321; VEGF Trap-Eye
Experimental: aflibercept injection 2.0mg Q8	Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321); Participants received a 2.0mg dose of aflibercept injection 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.; Other Names: BAY86-5321; VEGF Trap-Eye; Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321); Participants received a 0.5mg dose of aflibercept injection 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.; Other Names: BAY86-5321; VEGF Trap-Eye; Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321); Participants received a 2.0mg dose of aflibercept injection every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.; Other Names: BAY86-5321; VEGF Trap-Eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)	Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.	Baseline and at week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF	Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.	Baseline and at week 52
Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.	Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.	Baseline and at week 52
Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF	The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.	Baseline and at Week 52
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)	CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.	Baseline and at week 52

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Bayer
• Investigators: Study Director: Robert Vitti, MD, Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.
• Moshfeghi DM, Thompson D, Saroj N. Changes in neovascular activity following fixed dosing with an anti-vascular endothelial growth factor agent over 52 weeks in the phase III VIEW 1 and VIEW 2 studies. Br J Ophthalmol. 2020 Sep;104(9):1223-1227. doi: 10.1136/bjophthalmol-2019-315021. Epub 2019 Dec 11.
• Yuzawa M, Fujita K, Wittrup-Jensen KU, Norenberg C, Zeitz O, Adachi K, Wang EC, Heier J, Kaiser P, Chong V, Korobelnik JF. Improvement in vision-related function with intravitreal aflibercept: data from phase 3 studies in wet age-related macular degeneration. Ophthalmology. 2015 Mar;122(3):571-8. doi: 10.1016/j.ophtha.2014.09.024. Epub 2014 Nov 6.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 31, 2007
• First Submitted That Met QC Criteria: July 31, 2007
• First Posted (Estimate): August 1, 2007

Study Record Updates

• Last Update Posted (Estimate): December 28, 2012
• Last Update Submitted That Met QC Criteria: December 20, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab; Aflibercept
• Other Study ID Numbers: VGFT-OD-0605