A Study to Evaluate Real-world Brolucizumab Effectiveness and Safety in Japanese Patients With Neovascular Age-related Macular Degeneration (nAMD)
- Conditions
- Neovascular Age-Related Macular Degeneration
- Registration Number
- NCT06699914
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 438
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Patients With Absence of Intra-retinal Fluid (IRF) and Absence of Subretinal Fluid (SRF) at Month 12 Month 12 Number of Patients With Absence of IRF and Absence of SRF at Month 3, 6, 9, and 18 Month 3, 6, 9, and 18
- Secondary Outcome Measures
Name Time Method Demographic: Number of Patients per Age Category Baseline Age categories:
* Less than 80 years old.
* 80 years or older.Demographic: Gender Baseline Number of Patients per Clinical Characteristic Baseline 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) fluidClinical Characteristic: Time Between Diagnosis and First Brolucizumab Injection Baseline Clinical Characteristic: Time Between Diagnosis and First Treatment Baseline Clinical Characteristic: Central Subfield Thickness (CSFT) Baseline Clinical Characteristic: Visual Acuity (VA) Baseline 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 letterClinical Characteristic: VA in Each Subtype Baseline VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded).
Number of Patients by Type of Previous Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment Up to 12 months pre-baseline Last Injection Interval of Anti-VEGF Treatment Before Switching Up to 12 months pre-baseline Number of Injections in the Last 6 Months Before Switching to Brolucizumab Up to 6 months pre-baseline Number of Injections in the Last 6 Months After Switching to Brolucizumab Up to 6 months post-baseline Number of Injections in the Last 12 Months Before Switching to Brolucizumab Up to 12 months pre-baseline Number of Injections in the Last 12 Months After Switching to Brolucizumab Up to 12 months post-baseline Number of Patients With Absence of Subretinal Fluid (SRF) Month 3, 6, 9, 12 and 18 Number of Patients with Absence of Intra-retinal Fluid (IRF) Month 3, 6, 9, 12, and 18 Number of Patients with Absence of Sub-retinal Pigment Epithelium (sub-RPE) Fluid Month 3, 6, 9, 12, and 18 Number of Patients with Absence of SRF and IRF Month 3, 6, 9, 12, and 18 Number of Patients with Absence of IRF, SRF, and sub-RPE Fluid Month 3, 6, 9, 12, and 18 Demographic: Age Baseline Time to Absence of Retinal Fluid During the First Year of Treatment Among Those With Presence of Retinal Fluid at Baseline 12 months Retinal fluid categories included:
* SRF
* IRF
* Sub-RPE
* SRF and IRF
* SRF, IRF, and sub-RPECentral Subfield Thickness (CFST) at Month 3, 6, 9, 12 and 18 Month 3, 6, 9, 12, and 18 Change in CFST From Baseline to Months 3, 6, 9, 12, and 18 Baseline, Month 3, 6, 9, 12, and 18 VA Change in Each Subtype From Baseline to Month 3 Baseline, Month 3 VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded).
VA Change in Each Subtype From Baseline to Month 6 Baseline, Month 6 VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded).
VA Change in Each Subtype From Baseline to Month 9 Baseline, Month 9 VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded).
VA Change in Each Subtype From Baseline to Month 12 Baseline, Month 12 VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded).
VA Change in Each Subtype From Baseline to Month 18 Baseline, Month 18 VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded).
Number of Brolucizumab Injections During the Study Within Specified Time Intervals Up to 18 months 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 monthsNumber of Non-injection Visits During Treatment With Brolucizumab Within Specified Time Intervals Up to 18 months 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 monthsNumber of Visits During Treatment With Brolucizumab Within Specified Time Intervals Up to 18 months 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 monthsNumber of Patients Categorized by Injection Intervals During Months 0 to 6 From Month 0 to Month 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 moreNumber of Patients Categorized by Injection Intervals During Months 0 to 12 From Month 0 to Month 12 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 moreNumber of Patients Categorized by Injection Intervals During Months 0 to 18 From Month 0 to Month 18 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 moreNumber of Patients Categorized by Injection Intervals During Months 13 to 18 From Month 13 to Month 18 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 moreNumber of Patients With a Change in Injection Interval at Month 12 Month 12 Changes in injection interval included:
* Prolonged (1 week or more)
* Stable
* Reduced (1 week or less)Number of Patients With Prophylactic Administration of Steroid Eye Drops Within Specified Time Intervals Up to 18 months Time intervals included:
* Month 0 to 3
* Month 3 to 6
* Month 6 to 12
* Month 13 to 18Number of Visits With Optical Coherence Tomography (OCT) Within Specified Time Intervals Up to 18 months Time intervals included:
* 0 to 6 months
* 0 to 12 months
* 0 to 18 months
* 13 to 18 monthsNumber of Visits Without OCT Within Specified Time Intervals Up to 18 months Time intervals included:
* 0 to 6 months
* 0 to 12 months
* 0 to 18 months
* 13 to 18 monthsPredictive Variables of VA Change From Baseline to Month 12 Baseline, 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.
Number of Patients Categorized by Criteria for Re-treatment Month 3, 6, 9, 12, and 18 Re-treatment criteria included VA, anatomic parameters, VA and anatomic parameters, and posology requirement.
Number of Patients Categorized by Criteria for No Re-treatment Month 3, 6, 9, 12, and 18 No re-treatment criteria included general visits and check of brolucizumab related intraocular inflammation (IOI).
Number of Patients who Switched to Another Anti-VEGF During Treatment With Brolucizumab Within Specified Time Intervals Up to 18 months Time intervals included:
* Month 0 to 3
* Month 3 to 6
* Month 6 to 9
* Month 9 to 12
* After 12 monthsNumber of Patients who Discontinued Treatment During the First Year Up to 12 months Number of Patients by Reason for Discontinuing Brolucizumab Treatment Up to 12 months Number of Patients With Adverse Events (AEs) Up to 12 months Number of Patients With Adverse Events of Special Interest (AESIs) and by Type of AESI Up to 12 months AESIs included endophthalmitis and Intraocular inflammation (IOI) including vasculitis and retinal vascular occlusion.
Number of AEs and AESIs per Patients Up to 12 months Number of Patients With AEs Categorized by Age and Gender Up to 12 months Number of Patients With AESIs Categorized by Age and Gender Up to 12 months Number of Patients With Brolucizumab-related AEs and AESIs Up to 12 months Number or Patients Who's AEs and AESIs Resolved Up to 12 months Number of Resolved AEs and AESIs Up to 12 months Time From First Brolucizumab Injection to AESIs Up to 12 months Best Corrected Visual Acuity (BCVA) Up to 12 months 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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (1)
Novartis
🇺🇸East Hanover, New Jersey, United States