Clinical trial NCT00509795: Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Degeneration
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2007-08-01
Enrollment: 1217
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)
timeFrame: Baseline and at week 52
Secondary outcomes:
measure: 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
timeFrame: Baseline and at week 52
measure: Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.
timeFrame: Baseline and at week 52
measure: Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF
timeFrame: Baseline and at Week 52
measure: Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)
timeFrame: Baseline and at week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Campbell
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Glendale
country: United States
state: California
city: Irvine
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Menlo Park
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Oakland
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Poway
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Ventura
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Yorba Linda
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Denver
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state: Colorado
city: Denver
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state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Hamden
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state: Connecticut
city: New Haven
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state: Connecticut
city: New London
country: United States
state: Connecticut
city: Altamonte Springs
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Fort Myers
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state: Florida
city: Ft. Lauderdale
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state: Florida
city: Ft. Myers
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city: Gainesville
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city: Jacksonville
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city: Miami
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city: Miami
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city: Mount Dora
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city: Orlando
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city: Orlando
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city: Oscala
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city: Palm Beach Gardens
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city: Pensacola
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city: Stuart
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city: Tampa
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city: Winter Haven
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city: Augusta
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state: Georgia
city: Aiea
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state: Hawaii
city: Honolulu
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city: Oak Brook
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state: Illinois
city: Fort Wayne
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state: Indiana
city: Indianapolis
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city: Indianapolis
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city: Indianapolis
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city: New Albany
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city: Iowa City
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state: Iowa
city: Wichita
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state: Kansas
city: Louisville
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state: Kentucky
city: Louisville
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state: Kentucky
city: Paducah
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state: Kentucky
city: New Orleans
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state: Louisiana
city: New Orleans
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state: Louisiana
city: Shreveport
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state: Louisiana
city: Bangor
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state: Maine
city: Portland
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state: Maine
city: Baltimore
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state: Maryland
city: Baltimore
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state: Maryland
city: Chevy Chase
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city: Hagerstown
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state: Maryland
city: Towson
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state: Maryland
city: Boston
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state: Massachusetts
city: Boston
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city: Boston
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state: Massachusetts
city: Peabody
country: United States
state: Massachusetts
city: Ann Arbor
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state: Michigan
city: Battle Creek
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state: Michigan
city: Detroit
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city: Grand Rapids
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city: Jackson
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city: Royal Oak
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city: Southfield
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state: Michigan
city: West Bloomfield
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state: Michigan
city: Edina
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state: Minnesota
city: Minneapolis
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city: Rochester
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city: Florissant
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city: Kansas City
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city: Kansas City
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city: Springfield
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city: St. Louis
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state: Missouri
city: Missoula
country: United States
state: Montana
city: Lincoln
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city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Lawrenceville
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Northfield
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city: Teaneck
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
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state: New York
city: Brooklyn
country: United States
state: New York
city: Lynbrook
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
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city: New York
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city: Poughkeepsie
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state: New York
city: Rochester
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city: Rochester
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state: New York
city: Slingerlands
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city: Syracuse
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city: Asheville
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state: North Carolina
city: Charlotte
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state: North Carolina
city: Raleigh
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state: North Carolina
city: Southern Pines
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state: North Carolina
city: Winston-Salem
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state: North Carolina
city: Cincinnati
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state: Ohio
city: Cincinnati
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state: Ohio
city: Columbus
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city: Toledo
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city: Oklahoma City
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state: Oklahoma
city: Ashland
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state: Oregon
city: Portland
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state: Oregon
city: Portland
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state: Oregon
city: Salem
country: United States
state: Oregon
city: Kingston
country: United States
state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsberg
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: West Mifflin
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: West Columbia
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Memphis
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Abilene
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Corpus Cristi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: DeSoto
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Charlottesville
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Silverdale
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Robert Vitti, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.