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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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)

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

NCT01722045•Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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
+13 more criteria

Locations (49)

Phoenix, Arizona, United States

Tucson, Arizona, United States

Beverly Hills, California, United States

Oakland, California, United States

Palm Desert, California, United States

Sacramento, California, United States

Santa Ana, California, United States

Westlake Village, California, United States

Colorado Springs, Colorado, United States

Golden, Colorado, United States

Key Dates

Start Date

November 1, 2012

Primary Completion Date

September 1, 2015

Completion Date

September 1, 2015

Last Updated

December 22, 2017

Enrollment

154

ACTUAL participants

Conditions

Age - Related Macular Degeneration (AMD)

Interventions

Intravitreal Aflibercept Injection (IAI)

DRUG