The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.
Patients attended 14 scheduled study visits during 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
712
0.5 mg intravitreal injection
2 mg intravitreal injection
Mean of the Absolute Values of CSRT Difference Month 3 to Month 6
The thickness of the retina was measured by Spectral Domain Optical Coherence Topography (SD-OCT). The mean of the absolute values of the CSRT difference between Month 3 and 4, Month 4 and 5, and Month 5 and 6 was calculated (ie, CSRT fluctuation). A lower average CSRT fluctuation demonstrates greater retinal stability. One eye (study eye) contributed to the analysis.
Time frame: Month 3, Month 4, Month 5, Month 6
Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12
Visual acuity was assessed in a sitting position with refraction using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. A higher score indicates better visual acuity. ETDRS scale ranges from 0-100 letters. A score of 65 to 70 letters represents a low to moderate visual acuity
Time frame: Month 12
IREST at Month 12
Number of incorrectly read words (IREST) was assessed using International Reading Speed Texts (IResT) and measured in words per minute.
Time frame: Month 12
National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12
Vision-related quality of life was assessed by the patient using the National Eye Institute Visual Function Questionnaire. The scores of 12 subscales (general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision) were added together for a total (composite) score, which ranged from 0 to 100. A higher score indicates poorer function.
Time frame: Month 12
Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set)
Correlation coefficient calculated based on Pearson's correlation between each corresponding parameter and CSRT stability.
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Novartis Investigative Site
Feldkirch, Austria
Novartis Investigative Site
Graz, Austria
Novartis Investigative Site
Linz, Austria
Novartis Investigative Site
Salzburg, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Laken, Belgium
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Glostrup Municipality, Denmark
Novartis Investigative Site
Roskilde, Denmark
...and 58 more locations
Time frame: Month 3 to Month 6, Month 12