A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD)
- Registration Number
- NCT03539549
- Lead Sponsor
- Allergan
- Brief Summary
The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- Male or female participants, 50 years of age or older at the time of informed consent
- 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
- Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye)
- Previous or concurrent macular laser treatment (study eye)
- Cataract or refractive surgery within 3 months prior to baseline (study eye)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Abicipar pegol 2 mg Abicipar pegol Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Stable Vision Baseline (Day 1) to Week 28 Stable vision was defined as a loss of fewer than 15 letters in Best Corrected Visual Acuity (BCVA) compared to baseline. BCVA was measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye Baseline (Day 1) to Week 28 BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Change Form Baseline in BCVA in the Study Eye Baseline (Day 1) to Week 28 BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye Baseline (Day 1) to Week 28 CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye Baseline (Day 1), Week 28 BCVA was measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye was defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
Trial Locations
- Locations (37)
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
N. California Retina Vitreous Associates Medical Group, INC.
🇺🇸Mountain View, California, United States
Georgia Retina, P.C.
🇺🇸Marietta, Georgia, United States
Marietta Eye Clinic
🇺🇸Marietta, Georgia, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Retina Vitreous Surgeons of Central NY, P.C.
🇺🇸Syracuse, New York, United States
Charleston Neuroscience Institute
🇺🇸Ladson, South Carolina, United States
Retina Consultants of Houston
🇺🇸The Woodlands, Texas, United States
Ophthalmic Consultants of Long Island
🇺🇸Lynbrook, New York, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Retinal Consultants of Houston
🇺🇸Houston, Texas, United States
Retinal Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Barnet Dulaney Perkins Eye Center
🇺🇸Phoenix, Arizona, United States
Retinal Consultants Medical Group, Inc.
🇺🇸Sacramento, California, United States
Retina Associates Southwest, PC
🇺🇸Tucson, Arizona, United States
Win Retina
🇺🇸Arcadia, California, United States
Mark B. Kislinger, MD, Inc.
🇺🇸Glendora, California, United States
Atlantis Retina Institute (Atlantis Eyecare)
🇺🇸Huntington Beach, California, United States
California Eye Specialists Medical Group, Inc
🇺🇸Pasadena, California, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Colorado Retina Associates
🇺🇸Golden, Colorado, United States
Retina Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States
Sabates Eye Center
🇺🇸Leawood, Kansas, United States
Raj K. Maturi, MD, PC
🇺🇸Indianapolis, Indiana, United States
Gailey Eye Clinic
🇺🇸Bloomington, Illinois, United States
Capital Region Retina, PLLC
🇺🇸Albany, New York, United States
Retina Associates of Western New York
🇺🇸Rochester, New York, United States
Pennsylvania Retina Specialists, P.C.
🇺🇸Camp Hill, Pennsylvania, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Texas Retina Associates
🇺🇸Arlington, Texas, United States
Texan Eye
🇺🇸Austin, Texas, United States
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Strategic Clinical Research Group, LLC
🇺🇸Willow Park, Texas, United States
Premiere Retina Specialists
🇺🇸Midland, Texas, United States
Retina Institute of Virginia
🇺🇸Richmond, Virginia, United States