Clinical trial NCT05266495: Effectiveness of Brolucizumab in Pre-treated Patients With nAMD in the Real-world Setting
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neovascular Age-related Macular Degeneration
Keywords: nAMD
brolucizumab
NIS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that started brolucizumab treatment during the study recruitment period or patients that started brolucizumab treatment during the 6 months preceding the start of study recruitment

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.

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

Primary outcomes:
measure: Percentage of patients with absence of SRF and IRF
timeFrame: Month 12
Secondary outcomes:
measure: Percentage of patients ≥ 80 years old
timeFrame: Baseline
measure: Duration of diagnosis
timeFrame: Baseline
measure: Percentage of patients with baseline visit
timeFrame: Baseline
measure: Percentage of patients with bilateral disease
timeFrame: Baseline
measure: Percentage of patients with lesion type
timeFrame: Baseline
measure: Percentage of patients with presence of SRF, IRF and sub-RPE
timeFrame: Baseline
measure: Baseline CST
timeFrame: Baseline, Month 3, Month 6, Month 9 and Month 12
measure: Baseline VA
timeFrame: Baseline
measure: Percentage of patients with the study eye that has VA equal or less than the VA in fellow eye
timeFrame: Baseline
measure: Percentage of patients with baseline VA in the following categories (≤35, 36-69, ≥ 70 ETDRS letters)
timeFrame: Baseline
measure: Percentage of patients with VA between 34 and 72 ETDRS letters
timeFrame: Baseline
measure: Percentage of patients with baseline VA < 73 ETDRS letters and active (SRF only)
timeFrame: Baseline
measure: Percentage of patients with different ethnic groups
timeFrame: Baseline
measure: Switch Patients: Previous anti-VEGF treatments of nAMD pre-treated patients
timeFrame: Baseline
measure: Switch Patients: Duration of previous anti-VEGF treatments
timeFrame: Baseline
measure: Switch Patients: Number of injections in the last year before switching to brolucizumab
timeFrame: Baseline
measure: Switch Patients: Last interval of anti-VEGF treatment before switching
timeFrame: Baseline
measure: Percentage of patients with absence of SRF
timeFrame: Month 3, Month 6, Month 9 and Month 12
measure: Percentage of patients with stable SRF
timeFrame: Month 3, Month 6, Month 9 and Month 12
measure: Time to absence of SRF during the 12-month treatment with brolucizumab
timeFrame: 12 months
measure: Percentage of patients with absence of IRF
timeFrame: Month 3, Month 6, Month 9 and Month 12
measure: Percentage of patients with stable IRF
timeFrame: Month 3, Month 6, Month 9 and Month 12
measure: Time to absence of IRF during the 12-month treatment with brolucizumab
timeFrame: 12 months
measure: Percentage of patients with absence of sub-RPE
timeFrame: Month 3, Month 6, Month 9 and Month 12
measure: Percentage of patients with stable sub-RPE
timeFrame: Month 3, Month 6, Month 9 and Month 12
measure: Time to absence of sub-RPE during the 12-month treatment with brolucizumab
timeFrame: 12 months
measure: Percentage of patients with absence of SRF, IRF and sub-RPE
timeFrame: Month 3, Month 6, Month 9 and Month 12
measure: Time to absence of IRF and SRF and sub-RPE during the 12-month treatment with brolucizumab
timeFrame: 12 months
measure: Estimate CST change from baseline
timeFrame: Month 3, Month 6, Month 9 and Month 12
measure: Percentage of patients with reduced CST vs baseline
timeFrame: Baseline, Month 3, Month 6, Month 9 and Month 12
measure: Association between CST variability at Months 1-12 and VA change from baseline
timeFrame: Month 3, Month 6, Month 9 and Month 12
measure: Association between CST variability at Months 1-12 and number of injections
timeFrame: Month 12
measure: Percentage of patients with clinician-graded subretinal fibrosis and/or macular atrophy
timeFrame: Month 12
measure: VA change from baseline
timeFrame: Baseline, Month 3, Month 6, Month 9 and Month 12
measure: Percentage of patients with VA change from baseline
timeFrame: Baseline, Month 3, Month 6, Month 9 and Month 12
measure: Percentage of patients with ≥ 70 ETDRS letters
timeFrame: Month 3, Month 6, Month 9 and Month 12
measure: Number of brolucizumab visits
timeFrame: Over Months 1-3, 3-6, 6-12 and 1-12
measure: Distribution of injection intervals
timeFrame: During Months 1-6 and 1-12
measure: Percentage of patients with at least one duration of interval between injections
timeFrame: 12 months
measure: Percentage of patients with at least two consecutive duration of intervals between injections
timeFrame: 12 months
measure: Percentage of switch patients from other anti-VEGF that prolonged injection intervals with brolucizumab
timeFrame: Month 6, Month 9 and Month 12
measure: Percentage of patients with ≥ 3 brolucizumab injections
timeFrame: Month 3
measure: Number of participants by last recorded injection interval
timeFrame: Month 6 and Month 12
measure: Time between two consecutive brolucizumab injections
timeFrame: Over Months 1-3
measure: Number of visits with/without OCT
timeFrame: Over Months 1-6 and 1-12
measure: Association between number of OCT and CNV activity
timeFrame: Month 6, Month 9 and Month 12
measure: Association between number of OCT and VA change from baseline
timeFrame: Month 6, Month 9 and Month 12
measure: Association between number of OCT and number of injections
timeFrame: 12 months
measure: proportion of participants by baseline CNV activity
timeFrame: Baseline
measure: Proportion of participants with and without Loading phase
timeFrame: 12 months
measure: VA at the end of the loading phase
timeFrame: Month 3
measure: CNV activity at the end of the loading phase
timeFrame: Month 3
measure: Number of injections during the maintenance phase
timeFrame: Over months 3-12
measure: Percentage of patients with geographic atrophy
timeFrame: 12 Months
measure: Percentage of patients with subretinal fibrosis
timeFrame: 12 Months
measure: Assessment of criteria for no retreatment
timeFrame: 12 months
measure: Percentage of patients who switch to another anti-VEGF
timeFrame: 6 Months, 9 Months and 12 Months
measure: VA at time of switch
timeFrame: Up to 12 months
measure: Percentage of patients with activity at time of switch
timeFrame: Up to 12 months
measure: Percentage of switchers with full loading phase
timeFrame: 12 months
measure: Percentage of patients by injection rate at pre-switch period
timeFrame: Up to 12 months
measure: Reason for switching to another anti-VEGF
timeFrame: 12 months
measure: Last recorded injection interval before switching
timeFrame: Month 6 and Month 12
measure: Duration of brolucizumab treatment before switching
timeFrame: Up to month 12
measure: Percentage of patients who discontinue therapy
timeFrame: Up to 12 months
measure: Days of persistence
timeFrame: Up to 12 Months
measure: Percentage of patients with AEs
timeFrame: 12 Months
measure: AE rate
timeFrame: Month 3, Month 6, Month 9 and Month 12
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: