Clinical trial NCT01722045: Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection)
Official title: An Open-Label Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection) in Patients With Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age - Related Macular Degeneration (AMD)
Keywords: AMD
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-11-06
Enrollment: 154
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: This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI.


Eligibility criteria: Inclusion criteria include but are not limited to:

1. Men or women great than or equal to 50 years of age with unilateral neovascular AMD
2. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
3. Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye
4. The CNV area must be at least 50% of total lesion size
5. Willing and able to comply with clinic visits and study-related procedures
6. Provide signed informed consent
7. Provide signed Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion criteria include but are not limited to:

1. Neovascular AMD in the fellow eye
2. Corneal endothelial measures as judged by an independent reading center
3. Any prior use of intraocular anti-VEGF treatment for neovascular AMD in either eye
4. Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema
5. History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening
6. History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening, or yttrium aluminum garnet (YAG) Capsulotomy within 3 months of screening
7. Contact lens wear in either eye within 6 months of screening
8. History of angle closure glaucoma in either eye
9. Intraocular laser therapy including selective laser trabeculoplasty (SLT), YAG, prophylactic peripheral iridotomy (PI) in either eye within 1 year of screening, or YAG Capsulotomy within 3 months of screening
10. History of cataract surgery requiring an anterior chamber intraocular lens implant at any time in either eye
11. Any prior ocular trauma (blunt or penetrating) in either eye
12. Embedded corneal foreign body in either eye
13. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
14. Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
15. Any prior ocular inflammation/infection in either eye within 3 months of the screening visit
16. Any prior use of amantadine
17. Significant pre-retinal fibrosis involving the macula in the study eye (where, in the opinion of the investigator, the pre-retinal fibrosis is causing distortion or traction on the central macular region which may be limiting vision, or inducing retinal edema/thickening, beyond that due to underlying CNV)
18. Intraocular pressure (IOP) greater than or equal to 30 mm Hg in the study eye at screening
19. Uncontrolled diabetes mellitus (DM) (HbA1c ≥8)
20. Current treatment with systemic anti-VEGF therapeutics at screening
21. Known serious allergy to the fluorescein sodium for injection in angiography
22. Participation in an investigational study within 30 days prior to the screening visit that involved treatment with any drug (excluding vitamins and minerals) or device.
23. Positive serum hCG pregnancy test at the screening visit

Primary outcomes:
measure: Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF)
timeFrame: Baseline to Week 100
Secondary outcomes:
measure: Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF)
timeFrame: Baseline to Week 100
measure: Percentage of Participants Who Gained ≥15 ETDRS Letters Compared With Baseline at Week 52 and Week 100 (LOCF)
timeFrame: At week 52 and At week 100
measure: Change From Baseline in Best Corrected Visual Acuity Score Through Week 52 (LOCF)
timeFrame: Baseline to Week 52
measure: Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF)
timeFrame: Baseline to Week 100
measure: Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF)
timeFrame: Baseline to Week 100
Other outcomes:
measure: Percent Change From Baseline in Corneal Endothelial Cell Density (ECD) at Week 24 and Week 52 in the Study Eye and the Fellow Eye - Endothelial Cell Density Evaluable Set (EES)
timeFrame: At week 24 and At week 52
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Oakland
country: United States
state: California
city: Palm Desert
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Golden
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Plantation
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: Oak Park
country: United States
state: Illinois
city: New Albany
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Jackson
country: United States
state: Michigan
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Portsmouth
country: United States
state: New Hampshire
city: Bloomfield
country: United States
state: New Jersey
city: Lawrenceville
country: United States
state: New Jersey
city: Northfield
country: United States
state: New Jersey
city: Teaneck
country: United States
state: New Jersey
city: Rochester
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Kingston
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Florence
country: United States
state: South Carolina
city: Ladson
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: Arlington
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: