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
| Type | Name | Description |
|---|---|---|
| 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 |
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.