Clinical trial NCT00964795: Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
Official title: An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Keywords: Eyes
Neovascular
Macular Degeneration
Retina
AMD
VEGF Trap-Eye
Best Corrected Visual Acuity
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2009-08-25
Enrollment: 323
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.

Detailed description: The dose evaluated in this study, Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg, will be the higher of the 2 dose strengths evaluated in parent study VGFT-OD-0605 (NCT00509795) and is the dose level administered in study VGFT-OD-0702 (NCT00527423), a long-term open-label extension study. For these reasons, this dose has been selected for this extension study.

Participants will be seen in the clinic for quarterly visits starting with day 1 to assess safety. Study drug will be administered on an as-needed basis at the discretion of the investigator with a minimum allowed interval of every 4 weeks and a maximum allowed interval of every 12 weeks. This study will assess the frequency that re-treatment is needed and the effect of continued Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) treatment on BCVA.

Eligibility criteria: Inclusion Criteria:

* Participation in Study VGFT-OD-0605 through week 96.
* In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment.

Exclusion Criteria:

* Presence of any condition that would jeopardize the patient's participation in this study.
* Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.

Primary outcomes:
measure: Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD
timeFrame: Baseline (day 1) through end of treatment (Week 180)
Secondary outcomes:
measure: Change in BCVA Letter Score (mLOCF)
timeFrame: Baseline through Week 116
Other outcomes:
measure: Summary of Treatment Duration (Weeks)
timeFrame: Baseline through end of treatment (Week 180)
measure: Summary of Study Duration (Weeks)
timeFrame: Baseline through end of treatment (Week 180)
Locations:
city: Birmingham (2 locations)
country: United States
state: Alabama
city: Phoenix (2 locations)
country: United States
state: Arizona
city: Tucson (2 locations)
country: United States
state: Arizona
city: Arcadia
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Campbell
country: United States
state: California
city: Fresno
country: United States
state: California
city: Fullerton
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: Palm Desert
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Mateo
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Yorba Linda
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver (2 Locations)
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: New Haven
country: United States
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 (2 locations)
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando (2 locations)
country: United States
state: Florida
city: Oscala
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Stuart
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Aiea
country: United States
state: Hawaii
city: Glenview
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: New Albany
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Bangor
country: United States
state: Maine
city: Portland
country: United States
state: Maine
city: Baltimore (3 Locations)
country: United States
state: Maryland
city: Chevy Chase
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Boston (2 Locations)
country: United States
state: Massachusetts
city: Peabody
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Battle Creek
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Jackson
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Florissant
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Portsmouth
country: United States
state: New Hampshire
city: Lawrenceville
country: United States
state: New Jersey
city: Northfield
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
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Lynbrook
country: United States
state: New York
city: New York (6 locations)
country: United States
state: New York
city: Rochester (2 locations)
country: United States
state: New York
city: Slingerlands
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Ashland
country: United States
state: Oregon
city: Portland (3 Locations)
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Kingston
country: United States
state: Pennsylvania
city: Philadelphia (3 locations)
country: United States
state: Pennsylvania
city: Pittsburgh (2 locations)
country: United States
state: Pennsylvania
city: West Mifflin
country: United States
state: Pennsylvania
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: Nashville
country: United States
state: Tennessee
city: Austin (3 Locations)
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth (2 locations)
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 (2 locations)
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Salt Lake City (2 locations)
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: Madison (2 Locations)
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: Montreal (2 locations)
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: