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

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• Macular Degeneration 1,474
• Wet Macular Degeneration 232

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 438 is above the median of 106 across 421 observational studies indexed under Macular Degeneration.

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Study population

Groups and cohorts

• Naive Group

  Japanese patients diagnosed with nAMD who did not receive any anti-vascular endothelial growth factor (VEGF) injections during the 12 months before receiving brolucizumab.

• Pre-treated Group

  Japanese patients diagnosed with nAMD who received at least one injection of another anti-VEGF treatment during the 12 months before receiving brolucizumab.

Primary outcomes

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

   Time frame: Month 12

2. 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

1. Demographic: Age

   Time frame: Baseline

2. Demographic: Number of Patients per Age Category

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

   Time frame: Baseline

3. Demographic: Gender

   Time frame: Baseline

4. 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

5. Clinical Characteristic: Time Between Diagnosis and First Brolucizumab Injection

   Time frame: Baseline

6. Clinical Characteristic: Time Between Diagnosis and First Treatment

   Time frame: Baseline

7. Clinical Characteristic: Central Subfield Thickness (CSFT)

   Time frame: Baseline

8. 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

9. 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

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

    Time frame: Up to 12 months pre-baseline

11. Last Injection Interval of Anti-VEGF Treatment Before Switching

    Time frame: Up to 12 months pre-baseline

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

    Time frame: Up to 6 months pre-baseline

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

    Time frame: Up to 6 months post-baseline

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

    Time frame: Up to 12 months pre-baseline

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

    Time frame: Up to 12 months post-baseline

16. Number of Patients With Absence of Subretinal Fluid (SRF)

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

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

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

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

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

19. Number of Patients with Absence of SRF and IRF

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

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

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

21. 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

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

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

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

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

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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

33. Number of Patients Categorized by Injection Intervals During Months 0 to 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

    Time frame: From Month 0 to Month 12

34. Number of Patients Categorized by Injection Intervals During Months 0 to 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

    Time frame: From Month 0 to Month 18

35. Number of Patients Categorized by Injection Intervals During Months 13 to 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

    Time frame: From Month 13 to Month 18

36. 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

37. 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

38. 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

39. 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

40. 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

41. 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

42. 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

43. 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

44. Number of Patients who Discontinued Treatment During the First Year

    Time frame: Up to 12 months

45. Number of Patients by Reason for Discontinuing Brolucizumab Treatment

    Time frame: Up to 12 months

46. Number of Patients With Adverse Events (AEs)

    Time frame: Up to 12 months

47. 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

48. Number of AEs and AESIs per Patients

    Time frame: Up to 12 months

49. Number of Patients With AEs Categorized by Age and Gender

    Time frame: Up to 12 months

50. Number of Patients With AESIs Categorized by Age and Gender

    Time frame: Up to 12 months

51. Number of Patients With Brolucizumab-related AEs and AESIs

    Time frame: Up to 12 months

52. Number or Patients Who's AEs and AESIs Resolved

    Time frame: Up to 12 months

53. Number of Resolved AEs and AESIs

    Time frame: Up to 12 months

54. Time From First Brolucizumab Injection to AESIs

    Time frame: Up to 12 months

55. 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