Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD
- Conditions
- Wet Age-related Macular Degeneration
- Interventions
- Registration Number
- NCT04932980
- Lead Sponsor
- Berner Augenklinik
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 80
- Active MNV secondary to nAMD, going along with clinically significant vision loss
- Patients aged 50 years or older of all sexes
- Presence of IRF and/or SRF and/or subretinal hyperreflective material affecting the central subfield of the study eye on OCT
- signed informed consent for this study prior to the screening visit
- If possible: availability of a smartphone and willingness to perform self-testing with the Alleye app (soft criteria)
- Any other cause of macular oedema
- Structural damage to the macula precluding a visual potential
- Optical media opacities not allowing an accurate performance of the protocol examinations
- Any intraocular surgery within three months prior to inclusion and history of any vitreoretinal surgery
- Advanced diabetic retinopathy potentially requiring any treatment within six months following inclusion or history of vitreal haemorrhage
- Presence of vitreoretinal traction or tractive epiretinal membrane affecting the fovea
- History of IVT with anti-VEGF or corticosteroids at any time in the study eye
- Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.
- Significantly worse functional prognosis in the other eye or only eye
- Women of childbearing potential not willing to use an effective method of contraception during treatment and until at least 3 months after the last treatment
- Pregnant or lactating women
- Any systemic auto-inflammatory and auto-immune disease requiring treatment
- Treatment with high-dose corticosteroids (Prednisone equivalent >5mg/day), immunosuppressive or immunomodulatory or anti-proliferative agents for any reason
- Inability or contraindications to undergo the investigated intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aflibercept ® rapid treatment extension (T&E) early treat and extend (T&E) 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. Brolucizumab ® rapid treatment extension (T&E) 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. Aflibercept ® rapid treatment extension (T&E) Aflibercept 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. Brolucizumab ® rapid treatment extension (T&E) Brolucizumab 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.
- Primary Outcome Measures
Name Time Method Number of injections given until week 52 52 weeks number injections received by patient
- Secondary Outcome Measures
Name Time Method Number of treatment failures 104 weeks number with treatment demand of less than 6 weeks at any time point
Injections until week 104 104 weeks number injections received by patient
Change in central subfield thickness (CST) 104 weeks change from baseline to week 104
Time until drying of retina 104 weeks mean interval until absence of intra- and subretinal fluid
portion of eyes without disease activity 104 weeks % patients with absence of intra- and subretinal fluid
Change in visual acuity 104 weeks change of VA in logRAD from baseline to week 104
eyes under treatment intervals of ≥12 weeks 104 weeks portion of eyes with stable disease under treatment intervals of ≥12 weeks
Portion of eyes gaining and loosing ≥5, ≥10, and ≥15 letters 104 weeks change from baseline to week 104
Maximal treatment interval extension 104 weeks mean treatment interval extension
Trial Locations
- Locations (1)
Berner Augenklinik
🇨🇭Bern, Switzerland