The purpose of the study was to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF protein levels in treatment naïve wet neovascular Age-related Macular Degeneration (wAMD) patients in a detailed time course.
A planned study visit schedule was established at the time of baseline visit (day 1) for all patients. Study assessments for patients were performed at screening visit, baseline (day 1), day 2, day 8 (± 1 day to allow for flexibility in scheduling) and as of day 15 through to day 169 at biweekly visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
41
Administered as an intravitreal injection
Administered as an intravitreal injection
Novartis Investigative Site
Cologne, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
München, Germany
Novartis Investigative Site
München, Germany
Standardized Area Under the Curve (AUC) for VEGF A Levels by SIMOA (Quanterix's Single Molecule Array) Method for the Comparative Phase
The AUC was calculated using the trapezoidal rule, where all available measurement between Day 1 and Week 12 were used. The AUC was standardized by dividing the calculated value by the number of days from first to last measurement.
Time frame: Baseline up to Week 12 visit (Days 1, 2, 8, 15, 29, 43, 57, 71, 85)
Systemic VEGF-A Protein Levels From Study Week 12 to 24
Systemic VEGF-A protein levels in patients switching from monthly 2 mg aflibercept injections to monthly 0.5 mg ranibizumab compared to patients treated with monthly 0.5 mg ranibizumab from baseline (standardized area under the curve)
Time frame: From study week 12 to 24 (Days 85, 99, 113, 127, 141, 155, 169)
Systemic VEGF-A Levels From Study Week 12 to 24 (Change From Baseline)
Adjustment of systemic VEGF-A levels of patients switching from aflibercept to ranibizumab to levels comparable to baseline or to levels comparable as in patients treated from baseline with ranibizumab
Time frame: From study week 12 to 24
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Novartis Investigative Site
Osnabrück, Germany
Novartis Investigative Site
Regensburg, Germany