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Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD

NCT04932980 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-08

No results posted yet for this study

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

Interventions

DRUG

Aflibercept

administration of anti-VEGF Aflibercept (Eylea)

DRUG

Brolucizumab

administration of anti-VEGF Brolucizumab (Beovu)

PROCEDURE

early treat and extend (T&E)

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

Sponsors & Collaborators

  • medignition AG

    collaborator UNKNOWN

  • Berner Augenklinik

    lead OTHER

Principal Investigators

  • Justus G. Garweg, Prof. Dr. med. · Berner Augenklinik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2027-06-30
Completion
2028-03-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04932980 on ClinicalTrials.gov