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Completed

NCT Number: NCT06699914

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of nAMD.
  • Patients 50 years of age or older at index.
  • Received first injection of brolucizumab during the index period.
  • Gave signed or verbal informed consent.

Exclusion criteria

  • 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.
  • Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date.
  • Patients who had any contraindication and were not eligible for treatment with brolucizumab according to the label.
  • 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).
  • Patients participating in parallel in an interventional clinical trial.
  • Patients participating in post-marketing surveillance with brolucizumab.

Treatment and study plan

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

    Time frame: Baseline

    Age categories:

    • Less than 80 years old.
    • 80 years or older.

  3. Demographic: Gender

    Time frame: Baseline

  4. Number of Patients per Clinical Characteristic

    Time frame: 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

  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)

    Time frame: 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

  9. Clinical Characteristic: VA in Each Subtype

    Time frame: Baseline

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

  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

    Time frame: 12 months

    Retinal fluid categories included:

    • SRF
    • IRF
    • Sub-RPE
    • SRF and IRF
    • SRF, IRF, and sub-RPE

  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

    Time frame: Baseline, Month 3

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

  25. VA Change in Each Subtype From Baseline to Month 6

    Time frame: Baseline, Month 6

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

  26. VA Change in Each Subtype From Baseline to Month 9

    Time frame: Baseline, Month 9

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

  27. VA Change in Each Subtype From Baseline to Month 12

    Time frame: Baseline, Month 12

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

  28. VA Change in Each Subtype From Baseline to Month 18

    Time frame: Baseline, Month 18

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

  29. Number of Brolucizumab Injections During the Study Within Specified Time Intervals

    Time frame: 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

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

    Time frame: 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

  31. Number of Visits During Treatment With Brolucizumab Within Specified Time Intervals

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: Month 12

    Changes in injection interval included:

    • Prolonged (1 week or more)
    • Stable
    • Reduced (1 week or less)

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

    Time frame: Up to 18 months

    Time intervals included:

    • Month 0 to 3
    • Month 3 to 6
    • Month 6 to 12
    • Month 13 to 18

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

    Time frame: Up to 18 months

    Time intervals included:

    • 0 to 6 months
    • 0 to 12 months
    • 0 to 18 months
    • 13 to 18 months

  39. Number of Visits Without OCT Within Specified Time Intervals

    Time frame: Up to 18 months

    Time intervals included:

    • 0 to 6 months
    • 0 to 12 months
    • 0 to 18 months
    • 13 to 18 months

  40. Predictive Variables of VA Change From Baseline to Month 12

    Time frame: 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.

  41. Number of Patients Categorized by Criteria for Re-treatment

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

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

  42. Number of Patients Categorized by Criteria for No Re-treatment

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

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

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

    Time frame: 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

  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

    Time frame: Up to 12 months

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

  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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: PHEASANT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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