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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00509795
First received: July 31, 2007
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
Biological: ranibizumab
Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and at week 52 ] [ Designated as safety issue: No ]
    Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.


Secondary Outcome Measures:
  • 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 [ Time Frame: Baseline and at week 52 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF. [ Time Frame: Baseline and at week 52 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF [ Time Frame: Baseline and at Week 52 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF) [ Time Frame: Baseline and at week 52 ] [ Designated as safety issue: No ]
    CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.


Enrollment: 1217
Study Start Date: August 2007
Study Completion Date: July 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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:
  • VEGF Trap-Eye
  • BAY86-5321
Experimental: aflibercept injection 0.5mg Q4 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:
  • VEGF Trap-Eye
  • BAY86-5321
Experimental: aflibercept injection 2.0mg Q8 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:
  • VEGF Trap-Eye
  • BAY86-5321

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509795

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35205
Birmingham, Alabama, United States, 35223
United States, Arizona
Phoenix, Arizona, United States, 85014
Phoenix, Arizona, United States, 85020
Tucson, Arizona, United States, 85704
Tucson, Arizona, United States, 85710
United States, 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, 90033
Los Angeles, California, United States, 90048
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
United States, Colorado
Aurora, Colorado, United States, 80045
Denver, Colorado, United States, 80205
Denver, Colorado, United States, 80230
United States, Connecticut
Bridgeport, Connecticut, United States, 06606
Hamden, Connecticut, United States, 06518
New Haven, Connecticut, United States, 06510
New London, Connecticut, United States, 06320
United States, 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, 32803
Orlando, Florida, United States, 32806
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
United States, Georgia
Augusta, Georgia, United States, 30909
United States, Hawaii
Aiea, Hawaii, United States, 96701
Honolulu, Hawaii, United States, 96813
United States, Illinois
Oak Brook, Illinois, United States, 60523
United States, Indiana
Fort Wayne, Indiana, United States, 46804
Indianapolis, Indiana, United States, 46202
Indianapolis, Indiana, United States, 46260
Indianapolis, Indiana, United States, 46280
New Albany, Indiana, United States, 47150
United States, Iowa
Iowa City, Iowa, United States, 52242-1091
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Louisville, Kentucky, United States, 40202
Louisville, Kentucky, United States, 40207
Paducah, Kentucky, United States, 42001
United States, Louisiana
New Orleans, Louisiana, United States, 70115
New Orleans, Louisiana, United States, 70121
Shreveport, Louisiana, United States, 71105
United States, Maine
Bangor, Maine, United States, 04401
Portland, Maine, United States, 04102
United States, Maryland
Baltimore, Maryland, United States, 21209
Baltimore, Maryland, United States, 21287
Chevy Chase, Maryland, United States, 20815
Hagerstown, Maryland, United States, 21740
Towson, Maryland, United States, 21204
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
Boston, Massachusetts, United States
Peabody, Massachusetts, United States, 01960
United States, 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
United States, Minnesota
Edina, Minnesota, United States, 55435
Minneapolis, Minnesota, United States, 55404
Rochester, Minnesota, United States, 55905
United States, Missouri
Florissant, Missouri, United States, 63031
Kansas City, Missouri, United States, 64108
Kansas City, Missouri, United States, 64111
Springfield, Missouri, United States, 65804
St. Louis, Missouri, United States, 63110
United States, Montana
Missoula, Montana, United States, 59801
United States, Nebraska
Lincoln, Nebraska, United States, 68506
Omaha, Nebraska, United States, 68131
United States, Nevada
Las Vegas, Nevada, United States, 89144
United States, 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
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, 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, 10003
New York, New York, United States, 10021
New York, New York, United States, 10032
Poughkeepsie, New York, United States, 12601
Rochester, New York, United States, 14620
Rochester, New York, United States, 14642
Slingerlands, New York, United States, 12159
Syracuse, New York, United States, 13224
United States, 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
United States, Ohio
Cincinnati, Ohio, United States, 45202
Cincinnati, Ohio, United States, 45242
Columbus, Ohio, United States, 43215
Toledo, Ohio, United States, 43608
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Ashland, Oregon, United States, 97520
Portland, Oregon, United States, 97210
Portland, Oregon, United States, 97227
Salem, Oregon, United States, 97302
United States, Pennsylvania
Kingston, Pennsylvania, United States, 18704
Philadelphia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19124
Philadelphia, Pennsylvania, United States, 19104
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
United States, Rhode Island
Providence, Rhode Island, United States, 02903-4928
United States, 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
United States, South Dakota
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Memphis, Tennessee, United States, 38119
Memphis, Tennessee, United States, 38120
Nashville, Tennessee, United States, 37203
United States, 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, 76102
Ft. Worth, Texas, United States, 76104
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
United States, Utah
Salt Lake City, Utah, United States, 84107
Salt Lake City, Utah, United States, 84132
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Charlottesville, Virginia, United States, 22908
Fairfax, Virginia, United States, 22031
Richmond, Virginia, United States, 23221
United States, Washington
Seattle, Washington, United States, 98104
Silverdale, Washington, United States, 98383
United States, Wisconsin
Madison, Wisconsin, United States, 53715
Madison, Wisconsin, United States, 58705
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Calgary, Alberta, Canada, T3E 7MB
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 3N9
Victoria, British Columbia, Canada, V8V 1B3
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
London, Ontario, Canada, N6A 4G5
Mississauga, Ontario, Canada, L4W 1W9
Ottawa, Ontario, Canada, K1H8L6
Toronto, Ontario, Canada, M5C 2T2
Toronto, Ontario, Canada, M4N3M5
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H3A 1A1
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4T 1A5
Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
Study Director: Robert Vitti, MD Regeneron Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00509795     History of Changes
Other Study ID Numbers: VGFT-OD-0605
Study First Received: July 31, 2007
Results First Received: December 16, 2011
Last Updated: December 20, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014