An interventional study of Aflibercept and Brolucizumab in Wet Age-related Macular Degeneration, sponsored by Berner Augenklinik. Active, not recruiting at 1 site in Switzerland. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Berner Augenklinik · Not applicable, Interventional, and Treatment
The currently widely established and preferred protocol for the treatment of wet age-related macular degeneration includes a loading phase of three monthly injections without interim adaptation or treatment according to disease activity, thereafter following a T\&E strategy with treatment adaptation in increments of 2-4 weeks according to disease activity. Based on pharmacological considerations regarding the vitreal half-life of the drugs, the aim of this prospective explorative study is to test whether an early extension of treatment intervals without a loading phase is an option without compromising functional outcomes. Based on a superiority of Afl compared to Ran with regard to achieving a dry retina after one year and based on studies, but in the absence of real-life experience with Bro, it seems of interest to test how far Afl and Bro are comparable in terms of their potential to extend the treatment intervals over 12 months, the time to dryness of the retina, and number of injections. Also, it is of high clinical relevance to demonstrate efficacy with longer initial treatment intervals compared to the current possibly over-treating loading-phase with three four-weekly injections.
Berner Augenklinik is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Early treat and extend (T\&E) with Aflibercept ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments.
Drug: Aflibercept · Procedure: early treat and extend (T&E)
Early treat and extend (T\&E) with Brolucizumab ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments.
Drug: Brolucizumab · Procedure: early treat and extend (T&E)
administration of anti-VEGF Aflibercept (Eylea)
administration of anti-VEGF Brolucizumab (Beovu)
extension of treatment intervals (T\&E) from the beginning of treatment
Number of injections given until week 52
number injections received by patient
Time frame: 52 weeks
Injections until week 104
number injections received by patient
Time frame: 104 weeks
Number of treatment failures
number with treatment demand of less than 6 weeks at any time point
Time frame: 52 weeks
Number of treatment failures
number with treatment demand of less than 6 weeks at any time point
Time frame: 104 weeks
Time until drying of retina
mean interval until absence of intra- and subretinal fluid
Time frame: 52 weeks
Time until drying of retina
mean interval until absence of intra- and subretinal fluid
Time frame: 104 weeks
portion of eyes without disease activity
% patients with absence of intra- and subretinal fluid
Time frame: 52 weeks
portion of eyes without disease activity
% patients with absence of intra- and subretinal fluid
Time frame: 104 weeks
eyes under treatment intervals of ≥12 weeks
portion of eyes with stable disease under treatment intervals of ≥12 weeks
Time frame: 52 weeks
eyes under treatment intervals of ≥12 weeks
portion of eyes with stable disease under treatment intervals of ≥12 weeks
Time frame: 104 weeks
Change in visual acuity
change of VA in logRAD from baseline to week 52
Time frame: 52 weeks
Change in visual acuity
change of VA in logRAD from baseline to week 104
Time frame: 104 weeks
Change in central subfield thickness (CST)
change from baseline to week 52
Time frame: 52 weeks
Change in central subfield thickness (CST)
change from baseline to week 104
Time frame: 104 weeks
Portion of eyes gaining and loosing ≥5, ≥10, and ≥15 letters
change from baseline to week 52
Time frame: 52 weeks
Portion of eyes gaining and loosing ≥5, ≥10, and ≥15 letters
change from baseline to week 104
Time frame: 104 weeks
Maximal treatment interval extension
mean treatment interval extension
Time frame: 52 weeks
Maximal treatment interval extension
mean treatment interval extension
Time frame: 104 weeks
Plan to share: No
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Berner Augenklinik