Last Update: Feb 22, 2024
Effectiveness of Brolucizumab in Pretreated Patients With nAMD in the Real-world Setting in Gulf Countries United Arab of Emirates, Kuwait , Bahrain , Oman and Qatar
ClinicalTrials.gov Identifier:
Novartis Reference Number:CRTH258AAE01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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.

Neovascular Age-related Macular Degeneration
Recruiting
99
Apr 13, 2022
Sep 30, 2024
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Other

Brolucizumab

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

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

Study Location

Novartis Investigative Site

Recruiting

Abu Dhabi,United Arab Emirates

Novartis Investigative Site

Recruiting

Abu Dhabi,112412,United Arab Emirates

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