Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD

NCT04932980 | Active Not Recruiting DMC

• 1 other identifier: SPARROW 2021-01236
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Wet Age-related Macular Degeneration

Keywords

wAMD; Treat & Extend; Aflibercept; Brolucizumab; Loading-phase

Outcome Measures

Primary Outcomes (1)

• Number of injections given until week 52

  number injections received by patient

  52 weeks

Secondary Outcomes (17)

• Injections until week 104

  104 weeks

• Number of treatment failures

  52 weeks

• Number of treatment failures

  104 weeks

• Time until drying of retina

  52 weeks

• Time until drying of retina

  104 weeks

Study Arms (2)

Aflibercept ® rapid treatment extension (T&E)

ACTIVE COMPARATOR

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)

Brolucizumab ® rapid treatment extension (T&E)

ACTIVE COMPARATOR

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)

Interventions

Brolucizumab DRUG

administration of anti-VEGF Brolucizumab (Beovu)

Brolucizumab ® rapid treatment extension (T&E)

early treat and extend (T&E) PROCEDURE

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

Aflibercept ® rapid treatment extension (T&E); Brolucizumab ® rapid treatment extension (T&E)

Aflibercept DRUG

administration of anti-VEGF Aflibercept (Eylea)

Aflibercept ® rapid treatment extension (T&E)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Berner Augenklinik: lead
• medignition AG: collaborator

Study Sites (1)

Berner Augenklinik

Bern, 3007, Switzerland

Location

Related Publications (2)

• Fauser S, Schwabecker V, Muether PS. Suppression of intraocular vascular endothelial growth factor during aflibercept treatment of age-related macular degeneration. Am J Ophthalmol. 2014 Sep;158(3):532-6. doi: 10.1016/j.ajo.2014.05.025. Epub 2014 May 28.

  PMID: 24879948 BACKGROUND

• Garweg JG, Gerhardt C. Disease stability and extended dosing under anti-VEGF treatment of exudative age-related macular degeneration (AMD) - a meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2021 Aug;259(8):2181-2192. doi: 10.1007/s00417-020-05048-1. Epub 2021 Feb 2.

  PMID: 33528645 BACKGROUND

MeSH Terms

Interventions

aflibercept; brolucizumab

Study Officials

• Justus G. Garweg, Prof. Dr. med.

  Berner Augenklinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-armed, randomized, double-blind

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 21, 2021
• Study Start: May 9, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)