Clinical trial NCT00527423: Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD
Official title: A Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Degeneration
Keywords: VEGF Trap-Eye
Macular Degeneration
AMD
Neovascular Age-Related Macular Degeneration
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2007-09-10
Enrollment: 157
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: Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.

Detailed description: Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).

Eligibility criteria: Inclusion Criteria:

* Prior participation in VEGF Trap-Eye Phase I and II studies

Exclusion Criteria:

* Any ocular or systemic adverse events that would preclude participation
* Presence of any condition that would jeopardize subject's participation

Primary outcomes:
measure: Number of Participants With Adverse Events (AE)
timeFrame: Baseline of this study to Wk 152
Secondary outcomes:
measure: Frequency (Number of Injections)
timeFrame: Baseline of this study to Wk 152
measure: Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values
timeFrame: Baseline of original study to Wk 156
Other outcomes:
Locations:
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Loma Linda
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: Westlake Village
country: United States
state: California
city: Ft. Myers
country: United States
state: Florida
city: Stuart
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Glenview
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: West Springfield
country: United States
state: Massachusetts
city: Toms River
country: United States
state: New Jersey
city: Lynbrook
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: W. 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
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: