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

NCT ID: NCT05266495

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-13
• Study Completion Date: 2023-03-13

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.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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)

Brolucizumab

Intervention Type: OTHER

There is no treatment allocation. Patients administered brolucizumab by prescription will be enrolled.

Interventions

Brolucizumab

There is no treatment allocation. Patients administered brolucizumab by prescription will be enrolled.

Intervention Type: OTHER

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

• Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Abu Dhabi, , United Arab Emirates

Countries

United Arab Emirates

Related Links

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18151

Results for CRTH258AAE01 that is getting linked from the Novartis Clinical Trials Website

Other Identifiers

CRTH258AAE01

Identifier Type: -

Identifier Source: org_study_id