To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)
330 Patients who have completed at least one year of treatment with aflibercept will be randomized to two different aflibercept regimens and followed for 76 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
336
A dose of 2 mg aflibercept injected intravitreally
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye
Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function.
Time frame: From baseline to Week 52
Percentage of Participants Maintaining Vision in the Study Eye
A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.
Time frame: At week 52
Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye
Time frame: At week 52
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Retinal characteristic was evaluated using Optical coherence tomography (OCT).
Time frame: From baseline to week 52
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye
Choroidal neovascularization measured by optical coherence tomography (OCT).
Time frame: From baseline to week 52
Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye
Time frame: At week 52
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Unnamed facility
Vienna, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Toronto, Ontario, Canada
Clinique medicale de l'oeil de l'Estrie
Sherbrooke, Quebec, Canada
Unnamed facility
Hradec Králové, Czechia
Unnamed facility
Pilsen, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Paris, Cedex 12, France
...and 61 more locations
Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire
National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) total score ranges from 0 to 100, where 100 represents the best possible score and 0 represents the worst.
Time frame: From baseline to week 52
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Time frame: Started after the first application of aflibercept in the study and less than or equal to 30 days after the last dose of study drug over approximately 1.5 years