Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)
NCT ID: NCT00509795
Last Updated: 2012-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1217 participants
INTERVENTIONAL
2007-08-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ranibizumab 0.5mg Q4
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.
aflibercept injection 2.0mg Q4
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.
aflibercept injection 0.5mg Q4
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.
aflibercept injection 2.0mg Q8
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.
Interventions
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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.
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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Vitti, MD
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Beverly Hills, California, United States
Campbell, California, United States
Fullerton, California, United States
Glendale, California, United States
Irvine, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Menlo Park, California, United States
Mountain View, California, United States
Oakland, California, United States
Palm Springs, California, United States
Pasadena, California, United States
Poway, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Torrance, California, United States
Ventura, California, United States
Westlake Village, California, United States
Yorba Linda, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Bridgeport, Connecticut, United States
Hamden, Connecticut, United States
New Haven, Connecticut, United States
New London, Connecticut, United States
Altamonte Springs, Florida, United States
Boynton Beach, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Mt. Dora, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Oscala, Florida, United States
Palm Beach Gardens, Florida, United States
Pensacola, Florida, United States
Sarasota, Florida, United States
Stuart, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
Honolulu, Hawaii, United States
‘Aiea, Hawaii, United States
Oak Brook, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
New Albany, Indiana, United States
Iowa City, Iowa, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Paducah, Kentucky, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Bangor, Maine, United States
Portland, Maine, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
Hagerstown, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Peabody, Massachusetts, United States
Ann Arbor, Michigan, United States
Battle Creek, Michigan, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Jackson, Michigan, United States
Royal Oak, Michigan, United States
Southfield, Michigan, United States
West Bloomfield, Michigan, United States
Edina, Minnesota, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Florissant, Missouri, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Lawrenceville, New Jersey, United States
New Brunswick, New Jersey, United States
Northfield, New Jersey, United States
Teaneck, New Jersey, United States
Toms River, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Brooklyn, New York, United States
Lynbrook, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Rochester, New York, United States
Rochester, New York, United States
Slingerlands, New York, United States
Syracuse, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Southern Pines, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Ashland, Oregon, United States
Portland, Oregon, United States
Portland, Oregon, United States
Salem, Oregon, United States
Kingston, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsberg, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
West Mifflin, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
West Columbia, South Carolina, United States
Rapid City, South Dakota, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Corpus Cristi, Texas, United States
Dallas, Texas, United States
DeSoto, Texas, United States
Fort Worth, Texas, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
Odessa, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Charlottesville, Virginia, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Silverdale, Washington, United States
Madison, Wisconsin, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Regina, Saskatchewan, Canada
Countries
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References
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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.
Other Identifiers
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VGFT-OD-0605
Identifier Type: -
Identifier Source: org_study_id