Neovascular Age-Related Macular Degeneration
Conditions
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) fluid |
| Clinical 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 letter |
| Clinical 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 | — |
| 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-RPE |
| Central 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 months |
| Number 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 months |
| Number 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 months |
| Number 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 more |
| Number 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 more |
| Number 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 more |
| Number 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 more |
| Number 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 18 |
| Number 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 months |
| Number 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 months |
| Predictive 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 months |
| Number 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 | — |
| Demographic: Age | Baseline | — |
| 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. |
| Number of Patients With AESIs Categorized by Age and Gender | Up to 12 months | — |
| Demographic: Number of Patients per Age Category | Baseline | Age categories: * Less than 80 years old. * 80 years or older. |
Countries
United States
Outcome results
None listed