In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,011
Solution in Vial, intravitreal (IVT) injection
Solution in Vial, 2 mg, intravitreal (IVT) injection
Arizona Retina & Vitreous Consultants - Central Phoenix Phoenix
Phoenix, Arizona, United States
Retina Consultants of Orange County - Fullerton
Fullerton, California, United States
Northern California Retina Vitreous Associates - Mountain View Office
Mountain View, California, United States
Azul Vision Pasadena
Pasadena, California, United States
Retina Consultants San Diego - Poway
Poway, California, United States
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
Time frame: At baseline and Week 48
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60
Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).
Time frame: At baseline and Week 60
Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16
Time frame: At Week 16
Percentage of Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 48
Time frame: At baseline and Week 48
Percentage of Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 48
Time frame: At Week 48
Change in Choroidal Neovascularization (CNV) Size From Baseline to Week 48
Time frame: At baseline and Week 48
Change in Total Lesion Area From Baseline to Week 48
Time frame: At baseline and Week 48
Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in the Center Subfield at Week 48
Time frame: At Week 48
Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 48
Time frame: At baseline and Week 48
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Total Score at Week 48
NEI VFQ-25 was a 25-item questionnaire that gave a score on a scale from 0 (worst) to 100 (best = no vision problems)
Time frame: At baseline and Week 48
Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Week 48
Time frame: Up to Week 48
Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response
Time frame: Up to week 96
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Retina Consultants of Southern California
Redlands, California, United States
Kaiser Permanente Riverside Medical Center - Cardiology
Riverside, California, United States
Perlman Medical Offices at UC San Diego Health - Endocrinology
San Diego, California, United States
Retina Consultants of Southern Colorado, PC
Colorado Springs, Colorado, United States
New England Retina Associates
New London, Connecticut, United States
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