The purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF levels in DME patients in a detailed time course.
The purpose of the study is to compare the effect of monthly intravitreal injections of 0.5 mg ranibizumab and 2.0 mg aflibercept on systemic VEGF levels in patients with visual impairment due to DME over a 24 week period. In addition, the study will also assess the effect on systemic VEGF-A levels when patients are switched from aflibercept to ranibizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
0.5 mg intravitreal injections
2 mg intravitreal injections
Area under the curve (AUC) of VEGF-A levels from baseline to week 24
Systemic VEGF-A levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept (Area under the curve) expressed in pg/ml\*days. The AUC will be standardized (=divided) by the individual follow-up time and will be calculated by the trapezoidal rule..
Time frame: baseline to week 24
Mean Systemic VEGF-A levels in serum for patients in treatment group 1 and treatment group 2 within specific time points
To compare systemic VEGF-A levels (pg/ml) in patients switching from monthly 2 mg aflibercept injections for first three months to monthly 0.5 mg ranibizumab (treatment group 2) for the next three months compared to patients treated with monthly 0.5 mg ranibizumab (treatment group 1) for six months at specific time points from week 12 to week 24. The comparison will be performed at specific time points between week 12 and week 24, based on the blood samples collected for visits 10 to 16.
Time frame: Day 7, Day 15, Week 4, week 8, week 12, week 14, week 16, week 18, week 20, week 24
Mean Systemic VEGF-A levels in serum for patients in treatment group 1 and treatment group 3 within specific time points
To compare systemic VEGF-A levels (pg/ml) in patients switching from monthly 2 mg aflibercept injections for first three months to monthly 0.5 mg ranibizumab (treatment group 2) for the next three months compared to patients treated with monthly 2 mg aflibercept (treatment group 3) for six months at specific time points from week 12 to week 24. The comparison will be performed at specific time points between week 12 and week 24, based on the blood samples collected for visits 10 to 16.
Time frame: Day 7, Day 15, Week 4, week 8, week 12, week 14, week 16, week 18, week 20, week 24
Proportion of patients reporting ocular and/or systemic adverse events in all the three treatment groups.
To evaluate ocular and systemic safety in all the three treatment groups. Only treatment-emergent AEs will be summarized. AEs will be summarized by presenting for each treatment group the number and percentage of patients having any AE, having an eye-related AEs, having an AE in each primary system organ class and having each individual AEs based on the preferred term. All other information collected (e.g., severity or relationship to study treatment) will be tabulated and listed as appropriate. Summary tables will also be presented for the subset of AEs suspected to be treatment related.
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Time frame: From Baseline to Week 24