Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2028-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Wet Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two-armed, randomized, double-blind

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-blind

Study Groups

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Aflibercept ® rapid treatment extension (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.

Group Type ACTIVE_COMPARATOR

Aflibercept

Intervention Type DRUG

administration of anti-VEGF Aflibercept (Eylea)

early treat and extend (T&E)

Intervention Type PROCEDURE

extension of treatment intervals (T\&E) from the beginning of treatment

Brolucizumab ® rapid treatment extension (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.

Group Type ACTIVE_COMPARATOR

Brolucizumab

Intervention Type DRUG

administration of anti-VEGF Brolucizumab (Beovu)

early treat and extend (T&E)

Intervention Type PROCEDURE

extension of treatment intervals (T\&E) from the beginning of treatment

Interventions

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Aflibercept

administration of anti-VEGF Aflibercept (Eylea)

Intervention Type DRUG

Brolucizumab

administration of anti-VEGF Brolucizumab (Beovu)

Intervention Type DRUG

early treat and extend (T&E)

extension of treatment intervals (T\&E) from the beginning of treatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion 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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No