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)

NCT01722045 | Completed Phase 4 Results

• 1 other identifier: VGFTe-AMD-1124
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 49

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.

Conditions

Age - Related Macular Degeneration (AMD)

Keywords

AMD

Outcome Measures

Primary Outcomes (1)

• Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF)

  Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.

  Baseline to Week 100

Secondary Outcomes (5)

• Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF)

  Baseline to Week 100

• Percentage of Participants Who Gained ≥15 ETDRS Letters Compared With Baseline at Week 52 and Week 100 (LOCF)

  At week 52 and At week 100

• Change From Baseline in Best Corrected Visual Acuity Score Through Week 52 (LOCF)

  Baseline to Week 52

• Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF)

  Baseline to Week 100

• Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF)

  Baseline to Week 100

Other Outcomes (1)

• 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)

  At week 24 and At week 52

Study Arms (1)

Open label IAI

EXPERIMENTAL

Drug: Intravitreal Aflibercept Injection (IAI)

Interventions

Intravitreal Aflibercept Injection (IAI) DRUG

Open label IAI

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women great than or equal to 50 years of age with unilateral neovascular AMD
• BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
• 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
• The CNV area must be at least 50% of total lesion size
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent
• Provide signed Health Insurance Portability and Accountability Act (HIPAA) authorization

You may not qualify if:

• Neovascular AMD in the fellow eye
• Corneal endothelial measures as judged by an independent reading center
• Any prior use of intraocular anti-VEGF treatment for neovascular AMD in either eye
• 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
• History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening
• 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
• Contact lens wear in either eye within 6 months of screening
• History of angle closure glaucoma in either eye
• 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
• History of cataract surgery requiring an anterior chamber intraocular lens implant at any time in either eye
• Any prior ocular trauma (blunt or penetrating) in either eye
• Embedded corneal foreign body in either eye
• Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
• Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
• Any prior ocular inflammation/infection in either eye within 3 months of the screening visit

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (49)

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Beverly Hills, California, United States

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Oakland, California, United States

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Palm Desert, California, United States

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Sacramento, California, United States

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Santa Ana, California, United States

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Westlake Village, California, United States

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Colorado Springs, Colorado, United States

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Golden, Colorado, United States

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Boynton Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Pensacola, Florida, United States

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Plantation, Florida, United States

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Tampa, Florida, United States

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Winter Haven, Florida, United States

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Augusta, Georgia, United States

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Oak Park, Illinois, United States

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New Albany, Indiana, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Jackson, Michigan, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Portsmouth, New Hampshire, United States

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Bloomfield, New Jersey, United States

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Lawrenceville, New Jersey, United States

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Northfield, New Jersey, United States

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Teaneck, New Jersey, United States

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Rochester, New York, United States

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Asheville, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Kingston, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Florence, South Carolina, United States

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Ladson, South Carolina, United States

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West Columbia, South Carolina, United States

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Rapid City, South Dakota, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Seattle, Washington, United States

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MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Clinical Trial Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 22, 2017
• Results First Posted: December 22, 2017

Record last verified: 2017-11

Locations

US (49)