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Completed

NCT Number: NCT05037396

Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab

This was a retrospective cohort study to assess the treatment history, demographic characteristics, clinical characteristics, and early treatment patterns of patients who received brolucizumab for neovascular age-related macular degeneration using IRIS Registry.

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Key information

Conditions

Age-related Macular Degeneration (AMD) Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigational site

East Hanover, New Jersey, 07936-1080, United States

About this study

This was a retrospective cohort study of patients with wet AMD who received brolucizumab. Evidence was generated from the IRIS registry to describe patient treatment histories, demographic and clinical characteristics, and early treatment patterns.

Setting and study population:

IRIS Registry EHR data from 10/08/2018 to the 03/31/2020 from patients with wet AMD who initiated brolucizumab were analyzed.

Identification period of the index date: The patients fulfilling the selection criteria identified during the period from 10/08/2019 to 03/31/2020.

Index date: Defined as the date of the earliest brolucizumab injection.

Study Period: The period from 10/08/2018 to 03/31/2020.

Pre-index period: The period 12 months prior to the index date.

Post-index period: The period 4 months after the index date (not a required selection criterion; only for the assessment of select endpoints in a subgroup of patients).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with ≥1 brolucizumab injection
  • Diagnosis of wet AMD (ICD-10: H35.3210, H35.3211, H35.3212, H35.3213, H35.3220, H35.3221, H35.3222, H35.3223, H35.3230, H35.3231, H35.3232, H35.3233, H35.3290, H35.3291, H35.3292, and H35.3293) on the index date

Exclusion criteria

  • There were no exclusion criteria

Treatment and study plan

Brolucizumab

Drug

Participants received brolucizumab injection during the index period

Other names: BEOVU®

Primary outcomes

  1. Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months

    Time frame: Up to 4 months post brolucizumab injection

    To describe anti-VEGF treatment status (naive or switcher) in patients with wet AMD who initiated brolucizumab

Secondary outcomes

  1. Age information

    Time frame: Index date

    Age information was reported

  2. Gender information

    Time frame: Index date

    Gender information was reported

  3. Number of participants: Regions

    Time frame: 12-month period prior to index

    Northeast, North Central, South, West, Unknown

  4. Number of participants: Insurance type

    Time frame: 12-month period prior to index

    Private, Medicare, Medicare Advantage, Medicaid, Other

  5. Number of participants: Laterality

    Time frame: 12-month period prior to index

    Unilateral, Bilateral

  6. Number of participants: Race

    Time frame: 12-month period prior to index

    White, African American, Asian

  7. Number of participants: Concurrent eye disease

    Time frame: 12-month period prior to index

    Participants were measured at the eye level for the following eye diseases: Cataracts, Posterior vitreous detachment, Epiretinal membrane, Macular hole, Vitreomacular traction, Amblyopia, Pseudophakia, Glaucoma, Diabetic macular edema, Retinal vein occlusion, Diabetic retinopathy, Myopic choroidal neovascularization

  8. Number of participants: Provider specialty

    Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

    Participants were categorized based on provider specialty at date of first brolucizumab injection (e.g. Retina specialist, Ophthalmologist, etc)

  9. Encounter location (practice location)

    Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

    Midwest, Northeast, South, West, Unknown

  10. Eye location of brolucizumab injections

    Time frame: 12-month period prior to index

    e.g. OD [eye, right], OS [eye, left], Unspecified

  11. Index Visual acuity (VA)

    Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

    Visual acuity using Snellen and approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters).

    Snellen VA ranges:

    20/12-20/20 20/25-20/40 20/50-20/160 20/200 or worse

  12. Wet AMD diagnosis for the fellow eye

    Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

    Wet AMD diagnosis for the fellow eye as of the index date (Yes/No)

  13. Visual acuity of the fellow eye

    Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

    Visual acuity using Snellen and approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters).

    Snellen VA ranges:

    20/12-20/20 20/25-20/40 20/50-20/160 20/200 or worse

  14. Number of prior anti-VEGF treatments

    Time frame: 12-month period prior to index

    Number of anti-VEGF treatments used prior to brolucizumab at index by number of eyes were reported

  15. Type of prior anti-VEGF treatment among switchers to brolucizumab

    Time frame: 12-month period prior to index

    Type of anti-VEGF agent (aflibercept, bevacizumab, ranibizumab, unlicensed bevacizumab) used immediately prior to index were reported

  16. Prior anti-VEGF treatment sequence

    Time frame: 12-month period prior to index

    Prior treatment sequence(s) for previously treated eyes were reported. Continuous or Categorical (aflibercept, bevacizumab and ranibizumab)

  17. Number of prior anti-VEGF injections received prior to brolucizumab index date

    Time frame: 12-month period prior to index

    Total and Per treatment prior anti-VEGF injections received prior to brolucizumab index date were reported

  18. Injection intervals for the eyes that had received anti-VEGF injections prior to index

    Time frame: 12-month period prior to index

    Last injection interval, Average of last two injection intervals and Average of last three injection intervals were reported

  19. Anti-VEGF treatment status for the fellow eye

    Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

    Anti-VEGF treatment endpoints for the fellow eyes with wet AMD (Naive, Switcher) were reported

  20. Type of treatment for the fellow eye

    Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

    Following type of treatment for the fellow eye will be reported: aflibercept, bevacizumab, ranibizumab, brolucizumab, unlicensed bevacizumab, or none)

  21. The number of prior anti-VEGF treatments for the fellow eye

    Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

    Number of prior anti-VEGF injections for the fellow eye will be reported: Continuous or Categorical (e.g. 0, 1, ≥2)

  22. Number of brolucizumab injections received per study eye

    Time frame: Up to 4 months post index date

    Early treatment patterns after brolucizumab index date in anti-VEGF switcher and anti-VEGF naive patient eyes were reported

  23. The last injection interval

    Time frame: Up to 4 months post index date

    The length of the interval between the final two injections was reported

  24. The first injection interval after switch compared to last injection interval with a prior treatment

    Time frame: Up to 4 months post index date

    Longer, same or shorter interval were reported

  25. Type of anti-VEGF agent initiated after switching from index brolucizumab

    Time frame: First 3 months after switching from index brolucizumab

    Thr type of anti-VEGF agent initiated in the first 3 months after switching from index brolucizumab. were reported

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Treatment History, Demographic Characteristics, Clinical Characteristics, and Early Treatment Patterns of Patients Who Received Brolucizumab for Neovascular Age-related Macular Degeneration: IRIS Registry Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 8, 2021
Registry last updated
Oct 12, 2021

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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