Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-01-08 @ 1:03 PM
Study NCT ID:
NCT05266495
Status:
TERMINATED
Last Update Posted:
2025-01-13
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Brolucizumab in Pre-treated Patients With nAMD in the Real-world Setting
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
Effectiveness of Brolucizumab in Pretreated Patients With nAMD in the Real-world Setting in Gulf Countries United Arab of Emirates, Kuwait , Bahrain , Oman and Qatar
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a prospective and retrospective, observational, single-arm, non-randomized cohort study of ocular treatment with intravitreal injections of brolucizumab in nAMD patients. This study will be conducted prospectively and retrospectively (for patients who had their first brolucizumab injection before study start) using data collected in a standardized manner.
Detailed Description:
Retrospective data will be collected for all patients starting treatment with brolucizumab for up to 12 months before baseline.
Patients who received brolucizumab before the study start will be recruited into the study and presented an informed consent form (ICF) at their first visit. Their index date will be the date of their first brolucizumab injection, which must have occurred during the recruitment period or in 6 months prior to the first visit in the recruitment period. Patient history and characteristics will be recorded in the 12 months prior to the index date.
Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in the patient study eye.
Index period: The patients fulfilling the inclusion criteria will be identified during the period 01-Nov-2021 and onwards.
Study period: The period is between May-2020 and Nov-2023 to allow 6-month pre-index period and at least a 12-month follow-up period for each recruited patient.
Patients who received brolucizumab before the study start will be recruited into the study and presented an informed consent form (ICF) at their first visit. Their index date will be the date of their first brolucizumab injection, which must have occurred during the recruitment period or in 6 months prior to the first visit in the recruitment period. Patient history and characteristics will be recorded in the 12 months prior to the index date.
Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in the patient study eye.
Index period: The patients fulfilling the inclusion criteria will be identified during the period 01-Nov-2021 and onwards.
Study period: The period is between May-2020 and Nov-2023 to allow 6-month pre-index period and at least a 12-month follow-up period for each recruited patient.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: