Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498050
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-10
Brief Title:
Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema
Status:
RECRUITING
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:
BEST
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy of brolucizumab 6 mg in Chinese patients with persistent diabetic macular edema DME It will also learn about the safety of brolucizumab 6 mg
The main questions it aims to answer are
Does brolucizumab 6 mg reduce central subfield thickness CST and improve best-corrected visual acuity BCVA of participants What medical problems do participants have after receiving intravitreal injections of brolucizumab 6 mg Researchers will compare baseline CST and BCVA to those at each post-baseline visit to see if brolucizumab 6 mg works to treat persistent DME
Participants will
Receive brolucizumab 6 mg via intravitreal injections following two treatment patterns
Treatment Pattern 1 every 6 weeks for 5 injections Treatment Pattern 2 every 6 weeks for 3 injections followed by 1 injection after 12 weeks Visit the clinic 8 times for treatment and assessments over the course of 28 weeks
The main questions it aims to answer are
Does brolucizumab 6 mg reduce central subfield thickness CST and improve best-corrected visual acuity BCVA of participants What medical problems do participants have after receiving intravitreal injections of brolucizumab 6 mg Researchers will compare baseline CST and BCVA to those at each post-baseline visit to see if brolucizumab 6 mg works to treat persistent DME
Participants will
Receive brolucizumab 6 mg via intravitreal injections following two treatment patterns
Treatment Pattern 1 every 6 weeks for 5 injections Treatment Pattern 2 every 6 weeks for 3 injections followed by 1 injection after 12 weeks Visit the clinic 8 times for treatment and assessments over the course of 28 weeks
Detailed Description:
This study is a single-arm open-label study designed to evaluate the efficacy and safety of intravitreal injections IVI of brolucizumab 6 mg in Chinese subjects with persistent diabetic macular edema DME The study consists of a 2-week screening phase followed by a 28-week period from the point of informed consent
Intervention assessments and analyses will be performed in Guangdong Provincial Peoples Hospital Data from assessments will be extracted from the patients medical records at the following time points baseline Week 1 Week 6 Week 12 Week 16 Week 18 Week 24 and at Week 28
Safety data will be collected from any time point thoughout the study Any adverse events identified will be recorded and treated per recommended standard treatment guideline combined with local clinical practice
Intervention assessments and analyses will be performed in Guangdong Provincial Peoples Hospital Data from assessments will be extracted from the patients medical records at the following time points baseline Week 1 Week 6 Week 12 Week 16 Week 18 Week 24 and at Week 28
Safety data will be collected from any time point thoughout the study Any adverse events identified will be recorded and treated per recommended standard treatment guideline combined with local clinical practice
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