A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)
NCT ID: NCT03539549
Last Updated: 2020-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2018-05-25
2019-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Abicipar pegol 2 mg
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Abicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Interventions
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Abicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Eligibility Criteria
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Inclusion Criteria
* Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment) visits in the study eye
* BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to treatment) in the non-study eye
Exclusion Criteria
* Previous or concurrent macular laser treatment (study eye)
* Cataract or refractive surgery within 3 months prior to baseline (study eye)
50 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Joanne Li, MD
Role: STUDY_DIRECTOR
Allergan
Locations
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Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States
Retina Associates Southwest, PC
Tucson, Arizona, United States
Win Retina
Arcadia, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Mark B. Kislinger, MD, Inc.
Glendora, California, United States
Atlantis Retina Institute (Atlantis Eyecare)
Huntington Beach, California, United States
N. California Retina Vitreous Associates Medical Group, INC.
Mountain View, California, United States
California Eye Specialists Medical Group, Inc
Pasadena, California, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States
Colorado Retina Associates
Golden, Colorado, United States
Retina Specialty Institute
Pensacola, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Georgia Retina, P.C.
Marietta, Georgia, United States
Marietta Eye Clinic
Marietta, Georgia, United States
Gailey Eye Clinic
Bloomington, Illinois, United States
Raj K. Maturi, MD, PC
Indianapolis, Indiana, United States
Sabates Eye Center
Leawood, Kansas, United States
Sierra Eye Associates
Reno, Nevada, United States
Capital Region Retina, PLLC
Albany, New York, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Retina Associates of Western New York
Rochester, New York, United States
Retina Vitreous Surgeons of Central NY, P.C.
Syracuse, New York, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Pennsylvania Retina Specialists, P.C.
Camp Hill, Pennsylvania, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Texas Retina Associates
Arlington, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Texan Eye
Austin, Texas, United States
Retinal Consultants of Houston
Houston, Texas, United States
Premiere Retina Specialists
Midland, Texas, United States
Retinal Consultants of San Antonio
San Antonio, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1771-201-008
Identifier Type: -
Identifier Source: org_study_id
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