Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321302
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-03-14
Brief Title:
A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
CRIMSON A Multicentre Randomised Sham-controlled and Active Controlled in the USA Double-masked 72-week Trial to Study the Safety Tolerability Pharmacokinetics and Efficacy of 3 Dosing Regimens of Intravitreal BI 764524 in Patients With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This study is open to adults with diabetic retinopathy People who have non-proliferative diabetic retinopathy of moderate or high severity can join the study
The purpose of this study is to find out whether a medicine called BI 764524 helps people with diabetic retinopathy The study also aims to find a suitable treatment plan for BI 764524 Participants are put into 5 groups by chance Participants in groups 1 2 and 3 get BI 764524 Over 1 year they get a different number of injections of the same dose of BI 764524 injected into 1 eye During some visits participants may get a sham control which is done like an eye injection but without a needle so that participants will not know how many injections of BI 764524 they received Participants in group 4 only get a sham control Participants in group 5 only in the USA get aflibercept or sham injections during some visits Aflibercept is a medicine already used to treat diabetic retinopathy
Participants are in the study for one and a half years During this time they visit the study site at least 16 times During this time doctors regularly do eye exams and visual tests to assess the severity of participants eye condition After 1 year of treatment researchers look at the number of participants with eye improvements To do so they compare eye damage and certain severe eye problems between the groups of participants The doctors also regularly check participants health and take note of any unwanted effects
The purpose of this study is to find out whether a medicine called BI 764524 helps people with diabetic retinopathy The study also aims to find a suitable treatment plan for BI 764524 Participants are put into 5 groups by chance Participants in groups 1 2 and 3 get BI 764524 Over 1 year they get a different number of injections of the same dose of BI 764524 injected into 1 eye During some visits participants may get a sham control which is done like an eye injection but without a needle so that participants will not know how many injections of BI 764524 they received Participants in group 4 only get a sham control Participants in group 5 only in the USA get aflibercept or sham injections during some visits Aflibercept is a medicine already used to treat diabetic retinopathy
Participants are in the study for one and a half years During this time they visit the study site at least 16 times During this time doctors regularly do eye exams and visual tests to assess the severity of participants eye condition After 1 year of treatment researchers look at the number of participants with eye improvements To do so they compare eye damage and certain severe eye problems between the groups of participants The doctors also regularly check participants health and take note of any unwanted effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508891-12-00 | REGISTRY | None | None |
| U1111-1299-0915 | REGISTRY | Universal Trial Number | None |