Effectiveness of Brolucizumab in Pre-treated Patients Wit... | NCT05266495

Studies
Effectiveness of Brolucizumab in Pre-treated Patients With nAMD in the Real-world Setting

NCT05266495

Sponsor

Novartis Pharmaceuticals

Status

Terminated

Last Update Posted

Jan 13, 2025Actual

Enrollment

3Actual

Phase

Not provided

Conditions

Neovascular Age-related Macular Degeneration

Interventions

Brolucizumab

Countries

United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company Decision

Expanded Access Info

Start Date

Apr 13, 2022Actual

Primary Completion Date

Mar 13, 2023Actual

Completion Date

Mar 13, 2023Actual

First Submitted Date

Feb 23, 2022

First Submission Date that Met QC Criteria

Feb 23, 2022

First Posted Date

Mar 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2025

Last Update Posted Date

Jan 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brolucizumab		patients who received their first injection of Brolucizumab either during the active recruitment period (1 year prospective) or during the 6 months pre-start of the recruitment (6 months retrospective)	Other: Brolucizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brolucizumab	Other	There is no treatment allocation. Patients administered brolucizumab by prescription will be enrolled.	Brolucizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients with absence of SRF and IRF	percentage of treated patients with absence of SRF and IRF. Patients who have discontinued brolucizumab before Month 12 will be counted as not having achieved the endpoint of fluid resolution (absence of SRF and IRF), unless they reached it at the last visit while still on brolucizumab treatment before the discontinuation.	Month 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of patients ≥ 80 years old	Percentage of patients ≥ 80 years old will be collected	Baseline
Duration of diagnosis	Time since first diagnosis (years) will be collected

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of nAMD
Patients with ≥18 years of age at index
Receipt of at least one injection of brolucizumab (not necessarily the first one) during the index period
Signed informed consent

Exclusion Criteria:

Patients treated for retinal vein occlusion (RVO), diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
Receipt of any anti-VEGF treatment other than brolucizumab in the study eye during the index period
Receipt of brolucizumab in the study eye more than 6 months before the index period, i.e., brolucizumab treatment started more than 6 months before the start of the study
Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date
Patients who have any contraindication and are not eligible for treatment with brolucizumab as according to the label
Patients who were treated with more than 2 types of anti-VEGF before index date (4th line brolucizumab patients or more)
Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 12-month study participation
Patients participating in parallel in an interventional clinical trial Note: if a patient experiences an adverse event (AE), they may still be recruited in another study following this AE if they fulfill their inclusion criteria. Their data will still be collected as planned by the current protocol
Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients that started brolucizumab treatment during the study recruitment period or patients that started brolucizumab treatment during the 6 months preceding the start of study recruitment

Sampling Method

Non-Probability Sample