Ignite Creation Date:
2024-05-06 @ 4:17 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04932980
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-24
First Post:
2021-06-06
Brief Title:
Comparison of Rapid Aflibercept and Brolucizumab TE in wAMD
Sponsor:
Berner Augenklinik
Organization:
Berner Augenklinik
Study Overview
Official Title:
Study Comparing Early Extension of Aflibercept and Brolucizumab in Wet AMD SPARROW
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARROW
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 TE 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None