The purpose of this investigator initiated study is to identify the effects of intravitreal brolucizumab on recurrence-free treatment intervals and morphological features in choroidal neovascularizations (CNV) due to age-related macular degeneration (AMD) in which the Optical coherence tomography (OCT) guided treatment interval failed to be extended to 6, 8 or 10 weeks intervals in a treat and extend regimen using aflibercept.
Outcome Measures: The primary outcome is the mean maximum treatment interval with intravitreal brolucizumab at month 6 and 12. The secondary outcomes are: * Best corrected visual acuity (BCVA) in letters and BCVA change (letters) from baseline (=switch to brolucizumab) to month 6 and 12. * Number of brolucizumab intravitreal treatments applied during the 12 months study period. * Central retinal thickness (CRT, in µm) as measured in the central ETDRS subfield Spectral-Domain Optical coherence tomography (SD-OCT) at baseline, month 6 and 12. * Presence of qualitative SD-OCT features like intraretinal fluid, subretinal fluid, pigment epithelial detachment and hyperreflective foci at baseline, month 6 and 12. * Total CNV area and vessel density as measured by OCTangiography (OCTA) at baseline, month 6 and 12. * Total area of leakage from CNV and the total lesion area as evaluated by Fluorescein angiography (FA) at baseline and month 12. * VFQ-25 total and subscores as evaluated by quality of life questionnaire VFQ-25 at baseline and month 6 and 12. * Rates of adverse events and serious adverse events at 6 and 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
All consenting, enrolled patients (irrespectively of maximum recurrence-free interval under aflibercept pretreatment) will receive an intravitreal injection of brolucizumab 6 mg at baseline (week 0), at week 4 and each of the following treat and extend visits. At each visit all patients will undergo an OCT assessment. For all patients extension of treatment intervals is only possible 2-week-stepwise, e.g. 4, 6, 8 weeks etc.
Vista Klinik
Binningen, Basel-Landschaft, Switzerland
The primary outcome is the mean maximum treatment interval with intravitreal brolucizumab at month 6 and 12.
mean maximum treatment interval with intravitreal brolucizumab
Time frame: up to month 12
Best corrected visual acuity (BCVA) in letters
BCVA
Time frame: month 6 and 12
Number of brolucizumab intravitreal treatments applied during the 12 months study period.
Number of brolucizumab
Time frame: 12 months
Central retinal thickness (CRT, in µm) as measured in the central ETDRS subfield Spectral-Domain Optical coherence tomography (SD-OCT) at baseline, month 6 and 12.
CRT
Time frame: month 6 and 12
Presence of qualitative SD-OCT features like intraretinal fluid, subretinal fluid, pigment epithelial detachment and hyperreflective foci at baseline, month 6 and 12
SD-OCT
Time frame: month 6 and 12
Total CNV area and vessel density as measured by OCTangiography (OCTA) at baseline, month 6 and 12.
Total CNV area and vessel density
Time frame: month 6 and 12
Total area of leakage from CNV
Total area of leakage from CNV
Time frame: baseline and month 12
VFQ-25 total evaluated by quality of life questionnaire VFQ-25 at baseline and month 6 and 12.
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VFQ-25
Time frame: month 6 and 12
Rates of adverse events and serious adverse events at 6 and 12 months.
AE and SAE
Time frame: 6 and 12 months.
BCVA change (letters) from baseline (=switch to brolucizumab)
BCVA
Time frame: month 6 and 12
the total lesion area as evaluated by Fluorescein angiography (FA) at baseline and month 12
Total area of leakage from CNV
Time frame: baseline and month 12
VFQ-25 subscores
VFQ-25 subscores
Time frame: month 6 and 12