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Neovascular Age-Related Macular DegenerationPHEASANTNCT06699914

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

An observational study of Neovascular Age-Related Macular Degeneration, run by Novartis Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Type of treatment
Injection or infusion
How many people
438 participants
Where
1 siteUnited States
Study dates
6 Sep 2022to 1 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This was a retrospective, noninterventional cohort study.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Novartis

    East Hanover, New Jersey, 07936

Other trials in United States

About this study

Official 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

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06699914
Study groupRoleWhat they receive
Naive GroupJapanese 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 GroupJapanese patients diagnosed with nAMD who received at least one injection of another anti-VEGF treatment during the 12 months before receiving brolucizumab.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Month 12

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

    Measured: Month 3, 6, 9, and 18

Secondary outcomes (55)

  1. Demographic: Age

    Measured: Baseline

  2. Demographic: Number of Patients per Age Category

    Age categories:

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

    Measured: Baseline

  3. Demographic: Gender

    Measured: 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

    Measured: Baseline

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

    Measured: Baseline

  6. Clinical Characteristic: Time Between Diagnosis and First Treatment

    Measured: Baseline

  7. Clinical Characteristic: Central Subfield Thickness (CSFT)

    Measured: 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

    Measured: 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).

    Measured: Baseline

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

    Measured: Up to 12 months pre-baseline

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

    Measured: Up to 12 months pre-baseline

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

    Measured: Up to 6 months pre-baseline

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

    Measured: Up to 6 months post-baseline

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

    Measured: Up to 12 months pre-baseline

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

    Measured: Up to 12 months post-baseline

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

    Measured: Month 3, 6, 9, 12 and 18

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

    Measured: Month 3, 6, 9, 12, and 18

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

    Measured: Month 3, 6, 9, 12, and 18

  19. Number of Patients with Absence of SRF and IRF

    Measured: Month 3, 6, 9, 12, and 18

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

    Measured: 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

    Measured: 12 months

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

    Measured: Month 3, 6, 9, 12, and 18

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

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: 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).

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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

    Measured: Up to 18 months

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

    Measured: Up to 12 months

  45. Number of Patients by Reason for Discontinuing Brolucizumab Treatment

    Measured: Up to 12 months

  46. Number of Patients With Adverse Events (AEs)

    Measured: 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.

    Measured: Up to 12 months

  48. Number of AEs and AESIs per Patients

    Measured: Up to 12 months

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

    Measured: Up to 12 months

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

    Measured: Up to 12 months

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

    Measured: Up to 12 months

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

    Measured: Up to 12 months

  53. Number of Resolved AEs and AESIs

    Measured: Up to 12 months

  54. Time From First Brolucizumab Injection to AESIs

    Measured: 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.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2024
  2. Study start6 Sep 2022
  3. Primary completion1 Dec 2023
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
438 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06699914
Sponsor's protocol ID
CRTH258A1001
Acronym
PHEASANT
Status last verified
Nov 2024
First submitted
19 Nov 2024
Last updated
21 Nov 2024
Results posted
No

Publications

  • Ohnaka M, Sakurada Y, Hayashi A, Kadonosono K, Ohno H, Mori R, Matsumoto H, Nagamori I, Murata Y, Maio-Twofoot T, Karcher H, Takahashi H. Real-World Outcomes of Brolucizumab Treatment in Japanese Patients with Neovascular Age-Related Macular Degeneration: A 12-Month, Multicenter Study. Ophthalmol Ther. 2025 Jul;14(7):1551-1565. doi: 10.1007/s40123-025-01159-2. Epub 2025 May 28.

    PubMed 40434532

Questions about this trial

What is this clinical trial studying?

An observational study of Neovascular Age-Related Macular Degeneration, run by Novartis Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Absence of Intra-retinal Fluid (IRF) and Absence of Subretinal Fluid (SRF) at Month 12 (time frame: Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06699914, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

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