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

Novartis

Status: Terminated

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Other: Brolucizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05266495

CRTH258AAE01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

3 participants in 1 patient group

Brolucizumab

Description:

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)

Treatment:

Other: Brolucizumab