Clinical trial NCT06699914: A Study to Evaluate Real-world Brolucizumab Effectiveness and Safety in Japanese Patients With Neovascular Age-related Macular Degeneration (nAMD)
Official title: A Retrospective, 12-month, Multicenter Study to Evaluate Real-world Brolucizumab Effectiveness and Safety in Japanese Patients With Neovascular Age-related Macular Degeneration (nAMD) - the PHEASANT Study - a Study Following the Master Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age-Related Macular Degeneration
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 438
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients With Absence of Intra-retinal Fluid (IRF) and Absence of Subretinal Fluid (SRF) at Month 12
timeFrame: Month 12
measure: Number of Patients With Absence of IRF and Absence of SRF at Month 3, 6, 9, and 18
timeFrame: Month 3, 6, 9, and 18
Secondary outcomes:
measure: Demographic: Age
timeFrame: Baseline
measure: Demographic: Number of Patients per Age Category
timeFrame: Baseline
measure: Demographic: Gender
timeFrame: Baseline
measure: Number of Patients per Clinical Characteristic
timeFrame: Baseline
measure: Clinical Characteristic: Time Between Diagnosis and First Brolucizumab Injection
timeFrame: Baseline
measure: Clinical Characteristic: Time Between Diagnosis and First Treatment
timeFrame: Baseline
measure: Clinical Characteristic: Central Subfield Thickness (CSFT)
timeFrame: Baseline
measure: Clinical Characteristic: Visual Acuity (VA)
timeFrame: Baseline
measure: Clinical Characteristic: VA in Each Subtype
timeFrame: Baseline
measure: Number of Patients by Type of Previous Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment
timeFrame: Up to 12 months pre-baseline
measure: Last Injection Interval of Anti-VEGF Treatment Before Switching
timeFrame: Up to 12 months pre-baseline
measure: Number of Injections in the Last 6 Months Before Switching to Brolucizumab
timeFrame: Up to 6 months pre-baseline
measure: Number of Injections in the Last 6 Months After Switching to Brolucizumab
timeFrame: Up to 6 months post-baseline
measure: Number of Injections in the Last 12 Months Before Switching to Brolucizumab
timeFrame: Up to 12 months pre-baseline
measure: Number of Injections in the Last 12 Months After Switching to Brolucizumab
timeFrame: Up to 12 months post-baseline
measure: Number of Patients With Absence of Subretinal Fluid (SRF)
timeFrame: Month 3, 6, 9, 12 and 18
measure: Number of Patients with Absence of Intra-retinal Fluid (IRF)
timeFrame: Month 3, 6, 9, 12, and 18
measure: Number of Patients with Absence of Sub-retinal Pigment Epithelium (sub-RPE) Fluid
timeFrame: Month 3, 6, 9, 12, and 18
measure: Number of Patients with Absence of SRF and IRF
timeFrame: Month 3, 6, 9, 12, and 18
measure: Number of Patients with Absence of IRF, SRF, and sub-RPE Fluid
timeFrame: Month 3, 6, 9, 12, and 18
measure: Time to Absence of Retinal Fluid During the First Year of Treatment Among Those With Presence of Retinal Fluid at Baseline
timeFrame: 12 months
measure: Central Subfield Thickness (CFST) at Month 3, 6, 9, 12 and 18
timeFrame: Month 3, 6, 9, 12, and 18
measure: Change in CFST From Baseline to Months 3, 6, 9, 12, and 18
timeFrame: Baseline, Month 3, 6, 9, 12, and 18
measure: VA Change in Each Subtype From Baseline to Month 3
timeFrame: Baseline, Month 3
measure: VA Change in Each Subtype From Baseline to Month 6
timeFrame: Baseline, Month 6
measure: VA Change in Each Subtype From Baseline to Month 9
timeFrame: Baseline, Month 9
measure: VA Change in Each Subtype From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: VA Change in Each Subtype From Baseline to Month 18
timeFrame: Baseline, Month 18
measure: Number of Brolucizumab Injections During the Study Within Specified Time Intervals
timeFrame: Up to 18 months
measure: Number of Non-injection Visits During Treatment With Brolucizumab Within Specified Time Intervals
timeFrame: Up to 18 months
measure: Number of Visits During Treatment With Brolucizumab Within Specified Time Intervals
timeFrame: Up to 18 months
measure: Number of Patients Categorized by Injection Intervals During Months 0 to 6
timeFrame: From Month 0 to Month 6
measure: Number of Patients Categorized by Injection Intervals During Months 0 to 12
timeFrame: From Month 0 to Month 12
measure: Number of Patients Categorized by Injection Intervals During Months 0 to 18
timeFrame: From Month 0 to Month 18
measure: Number of Patients Categorized by Injection Intervals During Months 13 to 18
timeFrame: From Month 13 to Month 18
measure: Number of Patients With a Change in Injection Interval at Month 12
timeFrame: Month 12
measure: Number of Patients With Prophylactic Administration of Steroid Eye Drops Within Specified Time Intervals
timeFrame: Up to 18 months
measure: Number of Visits With Optical Coherence Tomography (OCT) Within Specified Time Intervals
timeFrame: Up to 18 months
measure: Number of Visits Without OCT Within Specified Time Intervals
timeFrame: Up to 18 months
measure: Predictive Variables of VA Change From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Number of Patients Categorized by Criteria for Re-treatment
timeFrame: Month 3, 6, 9, 12, and 18
measure: Number of Patients Categorized by Criteria for No Re-treatment
timeFrame: Month 3, 6, 9, 12, and 18
measure: Number of Patients who Switched to Another Anti-VEGF During Treatment With Brolucizumab Within Specified Time Intervals
timeFrame: Up to 18 months
measure: Number of Patients who Discontinued Treatment During the First Year
timeFrame: Up to 12 months
measure: Number of Patients by Reason for Discontinuing Brolucizumab Treatment
timeFrame: Up to 12 months
measure: Number of Patients With Adverse Events (AEs)
timeFrame: Up to 12 months
measure: Number of Patients With Adverse Events of Special Interest (AESIs) and by Type of AESI
timeFrame: Up to 12 months
measure: Number of AEs and AESIs per Patients
timeFrame: Up to 12 months
measure: Number of Patients With AEs Categorized by Age and Gender
timeFrame: Up to 12 months
measure: Number of Patients With AESIs Categorized by Age and Gender
timeFrame: Up to 12 months
measure: Number of Patients With Brolucizumab-related AEs and AESIs
timeFrame: Up to 12 months
measure: Number or Patients Who's AEs and AESIs Resolved
timeFrame: Up to 12 months
measure: Number of Resolved AEs and AESIs
timeFrame: Up to 12 months
measure: Time From First Brolucizumab Injection to AESIs
timeFrame: Up to 12 months
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: