A Study to Evaluate Real-world Brolucizumab Effectiveness and Safety in Japanese Patients With Neovascular Age-related Macular Degeneration (nAMD) (PHEASANT)

Novartis

Status: Completed

Conditions: Neovascular Age-Related Macular Degeneration

Study type: Observational

Funder types: Industry

Identifiers

NCT06699914

CRTH258A1001

Details and patient eligibility

About

A retrospective, observational, single-arm, non-randomized cohort study of ocular treatment in nAMD patients in Japan who had records of at least 12 months of follow-up after their first brolucizumab intravitreal injection. Patients who had records of at least 12 months of visits after the first brolucizumab injection (index date) were identified during the index period and were recruited during the data collection/recruitment period.

Enrollment: 438 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of nAMD.
2. Patients 50 years of age or older at index.
3. Received first injection of brolucizumab during the index period.
4. Gave signed or verbal informed consent.

Exclusion criteria

1. Patients treated for retinal vein occlusion (RVO), diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), and who had diagnoses of diabetes-related macular degeneration within 6 Months prior to the index date.
2. Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date.
3. Patients who had any contraindication and were not eligible for treatment with brolucizumab according to the label.
4. Patients who were treated with more than 3 types of anti-vascular endothelial growth factor (anti-VEGF) before the index date (5th line brolucizumab patients or more).
5. Patients participating in parallel in an interventional clinical trial.
6. Patients participating in post-marketing surveillance with brolucizumab.

Trial design

438 participants in 2 patient groups

Naive Group

Description:

Japanese patients diagnosed with nAMD who did not receive any anti-vascular endothelial growth factor (VEGF) injections during the 12 months before receiving brolucizumab.

Pre-treated Group

Description:

Japanese patients diagnosed with nAMD who received at least one injection of another anti-VEGF treatment during the 12 months before receiving brolucizumab.