Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT04932980

Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD

Study Comparing Early Extension of Aflibercept and Brolucizumab in Wet AMD (SPARROW)

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Berner Augenklinik · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DRUGAfliberceptadministration of anti-VEGF Aflibercept (Eylea)
DRUGBrolucizumabadministration of anti-VEGF Brolucizumab (Beovu)
PROCEDUREearly treat and extend (T&E)extension of treatment intervals (T\&E) from the beginning of treatment

Timeline

Start date
2022-05-09
Primary completion
2027-06-01
Completion
2028-03-01
First posted
2021-06-21
Last updated
2025-12-08

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04932980. Inclusion in this directory is not an endorsement.