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

Novartis Pharmaceuticals438 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

438

Conditions

Neovascular Age-Related Macular Degeneration

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Number of Patients With Absence of Intra-retinal Fluid (IRF) and Absence of Subretinal Fluid (SRF) at Month 12

Time frame: Month 12

Number of Patients With Absence of IRF and Absence of SRF at Month 3, 6, 9, and 18

Time frame: Month 3, 6, 9, and 18

Secondary Outcomes

Demographic: Age

Time frame: Baseline

Demographic: Number of Patients per Age Category

Age categories: * Less than 80 years old. * 80 years or older.

Time frame: Baseline

Demographic: Gender

Time frame: Baseline

Number of Patients per Clinical Characteristic

Clinical characteristics included: * Bilateral age-related macular degeneration (AMD) * Subtype of AMD, choroidal neovascularization (CNV) * CNV type (Type I, II, III, polypoidal choroidal vasculopathy (PCV) \[yes/no/not graded\]) * Intra-retinal fluid (IRF) * Subretinal fluid (SRF) * Presence of SRF and/or IRF * Absence of SRF and IRF * Sub-retinal pigment epithelium (sub-RPE) fluid

Time frame: Baseline

Clinical Characteristic: Time Between Diagnosis and First Brolucizumab Injection

Time frame: Baseline

Clinical Characteristic: Time Between Diagnosis and First Treatment

Time frame: Baseline

Clinical Characteristic: Central Subfield Thickness (CSFT)

Time frame: Baseline

Data from ClinicalTrials.gov

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Clinical Characteristic: Visual Acuity (VA)

Visual Acuity (VA) was measured with Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Conversion of VA readings to approximate ETDRS Letters: * For Snellen fraction decimal \>0.025 (\<logMAR1.60) the following formula was used: • approximate ETDRS Letters = 85+50\*log10 (Snellen fraction) * For Snellen fractions decimal ≤0.025 four bins were defined: * \>0.020 to 0.025 (logMAR 1.70 to 1.60) was 5 letters * \>0.015 to 0.020 (logMAR 1.82 to 1.70) was 3 letters * \>0.005 to 0.015 (logMAR 2.30 to 1.82) was 1 letter * ≤0.005 (logMAR ≥2.30) is 0 letter

Time frame: Baseline

Clinical Characteristic: VA in Each Subtype

VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded).

Time frame: Baseline

Number of Patients by Type of Previous Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment

Time frame: Up to 12 months pre-baseline

Last Injection Interval of Anti-VEGF Treatment Before Switching

Time frame: Up to 12 months pre-baseline

Number of Injections in the Last 6 Months Before Switching to Brolucizumab

Time frame: Up to 6 months pre-baseline

Number of Injections in the Last 6 Months After Switching to Brolucizumab

Time frame: Up to 6 months post-baseline

Number of Injections in the Last 12 Months Before Switching to Brolucizumab

Time frame: Up to 12 months pre-baseline

Number of Injections in the Last 12 Months After Switching to Brolucizumab

Time frame: Up to 12 months post-baseline

Number of Patients With Absence of Subretinal Fluid (SRF)

Time frame: Month 3, 6, 9, 12 and 18

Number of Patients with Absence of Intra-retinal Fluid (IRF)

Time frame: Month 3, 6, 9, 12, and 18

Number of Patients with Absence of Sub-retinal Pigment Epithelium (sub-RPE) Fluid

Time frame: Month 3, 6, 9, 12, and 18

Number of Patients with Absence of SRF and IRF

Time frame: Month 3, 6, 9, 12, and 18

Number of Patients with Absence of IRF, SRF, and sub-RPE Fluid

Time frame: Month 3, 6, 9, 12, and 18

Time to Absence of Retinal Fluid During the First Year of Treatment Among Those With Presence of Retinal Fluid at Baseline

Retinal fluid categories included: * SRF * IRF * Sub-RPE * SRF and IRF * SRF, IRF, and sub-RPE

Time frame: 12 months

Central Subfield Thickness (CFST) at Month 3, 6, 9, 12 and 18

Time frame: Month 3, 6, 9, 12, and 18

Change in CFST From Baseline to Months 3, 6, 9, 12, and 18

Time frame: Baseline, Month 3, 6, 9, 12, and 18

VA Change in Each Subtype From Baseline to Month 3

VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded).

Time frame: Baseline, Month 3

VA Change in Each Subtype From Baseline to Month 6

VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded).

Time frame: Baseline, Month 6

VA Change in Each Subtype From Baseline to Month 9

VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded).

Time frame: Baseline, Month 9

VA Change in Each Subtype From Baseline to Month 12

VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded).

Time frame: Baseline, Month 12

VA Change in Each Subtype From Baseline to Month 18

VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded).

Time frame: Baseline, Month 18

Number of Brolucizumab Injections During the Study Within Specified Time Intervals

Time intervals included: * 0 to 3 months * 3 to 6 months * 6 to 12 months * 13 to 18 months * 0 to 12 months * 0 to 18 months

Time frame: Up to 18 months

Number of Non-injection Visits During Treatment With Brolucizumab Within Specified Time Intervals

Time intervals included: * 0 to 3 months * 3 to 6 months * 6 to 12 months * 13 to 18 months * 0 to 12 months * 0 to 18 months

Time frame: Up to 18 months

Number of Visits During Treatment With Brolucizumab Within Specified Time Intervals

Time intervals included: * 0 to 3 months * 3 to 6 months * 6 to 12 months * 13 to 18 months * 0 to 12 months * 0 to 18 months

Time frame: Up to 18 months

Number of Patients Categorized by Injection Intervals During Months 0 to 6

Injection intervals (weeks) included: * Less than 4 weeks * ≥4 weeks but \<6 weeks * ≥6 weeks but \<8 weeks * ≥8 weeks but \<10 weeks * ≥10 weeks but \<12 weeks * ≥12 weeks but \<14 weeks * ≥14 weeks but \<16 weeks * ≥16 weeks but \<20 weeks * 12 weeks or more * 16 weeks or more * 20 weeks or more

Time frame: From Month 0 to Month 6

Number of Patients Categorized by Injection Intervals During Months 0 to 12

Time frame: From Month 0 to Month 12

Number of Patients Categorized by Injection Intervals During Months 0 to 18

Time frame: From Month 0 to Month 18

Number of Patients Categorized by Injection Intervals During Months 13 to 18

Time frame: From Month 13 to Month 18

Number of Patients With a Change in Injection Interval at Month 12

Changes in injection interval included: * Prolonged (1 week or more) * Stable * Reduced (1 week or less)

Time frame: Month 12

Number of Patients With Prophylactic Administration of Steroid Eye Drops Within Specified Time Intervals

Time intervals included: * Month 0 to 3 * Month 3 to 6 * Month 6 to 12 * Month 13 to 18

Time frame: Up to 18 months

Number of Visits With Optical Coherence Tomography (OCT) Within Specified Time Intervals

Time intervals included: * 0 to 6 months * 0 to 12 months * 0 to 18 months * 13 to 18 months

Time frame: Up to 18 months

Number of Visits Without OCT Within Specified Time Intervals

Time intervals included: * 0 to 6 months * 0 to 12 months * 0 to 18 months * 13 to 18 months

Time frame: Up to 18 months

Predictive Variables of VA Change From Baseline to Month 12

A multivariate regression model was used to assess the predictive value of VA change from baseline. Independent variables included age, baseline VA, baseline CNV activity, loading phase, VA (ETDRS letters) at the end of loading phase, CNV activity at the end of loading phase, PCV activity, number of injections, and geographic atrophy.

Time frame: Baseline, Month 12

Number of Patients Categorized by Criteria for Re-treatment

Re-treatment criteria included VA, anatomic parameters, VA and anatomic parameters, and posology requirement.

Time frame: Month 3, 6, 9, 12, and 18

Number of Patients Categorized by Criteria for No Re-treatment

No re-treatment criteria included general visits and check of brolucizumab related intraocular inflammation (IOI).

Time frame: Month 3, 6, 9, 12, and 18

Number of Patients who Switched to Another Anti-VEGF During Treatment With Brolucizumab Within Specified Time Intervals

Time intervals included: * Month 0 to 3 * Month 3 to 6 * Month 6 to 9 * Month 9 to 12 * After 12 months

Time frame: Up to 18 months

Number of Patients who Discontinued Treatment During the First Year

Time frame: Up to 12 months

Number of Patients by Reason for Discontinuing Brolucizumab Treatment

Time frame: Up to 12 months

Number of Patients With Adverse Events (AEs)

Time frame: Up to 12 months

Number of Patients With Adverse Events of Special Interest (AESIs) and by Type of AESI

AESIs included endophthalmitis and Intraocular inflammation (IOI) including vasculitis and retinal vascular occlusion.

Time frame: Up to 12 months

Number of AEs and AESIs per Patients

Time frame: Up to 12 months

Number of Patients With AEs Categorized by Age and Gender

Time frame: Up to 12 months

Number of Patients With AESIs Categorized by Age and Gender

Time frame: Up to 12 months

Number of Patients With Brolucizumab-related AEs and AESIs

Time frame: Up to 12 months

Number or Patients Who's AEs and AESIs Resolved

Time frame: Up to 12 months

Number of Resolved AEs and AESIs

Time frame: Up to 12 months

Time From First Brolucizumab Injection to AESIs

Time frame: Up to 12 months

Best Corrected Visual Acuity (BCVA)

BCVA was assessed before AESI onset, during AESI, and after AESI recovery. BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses. It is measured by ETDRS chart or Snellen chart.

Time frame: Up to 12 months