Study Description
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. 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.
Interventions
Brolucizumab
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
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