Clinical trial NCT02387957: A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Keywords: Wet AMD
subfoveal choroidal neovascularization
Fovista®
Avastin®
Lucentis®
Eylea®
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 63
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: To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

Detailed description: 60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows:

* Avastin® 1.25 mg/eye (20 subjects)
* Lucentis® 0.5 mg/eye (20 subjects)
* Eylea® 2.0 mg/eye (20 subjects)

Subjects will be stratified by lesion size (≤2 DA vs. \>2 DA).

Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months.

When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).

Eligibility criteria: Inclusion Criteria:

* Subjects of either gender aged ≥ 50 years.
* Active subfoveal choroidal neovascularization (CNV) due to AMD.

Exclusion Criteria:

* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
* Subjects with subfoveal scar or subfoveal atrophy
* Any ocular or periocular infection in the past twelve (12) weeks.
* History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.

Primary outcomes:
measure: Total Numer of Systemic Adverse Events
timeFrame: 2 years
measure: Total Number of Other Adverse Events (>5%)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: New London
country: United States
state: Connecticut
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Oak Forest
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Southfield
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Reno
country: United States
state: Nevada
city: Rochester
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Huntingdon Valley
country: United States
state: Pennsylvania
city: Ladson
country: United States
state: South Carolina
city: Abilene
country: United States
state: Texas
city: Amarillo
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Silverdale
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
Study officials:
References: