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Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05082415
Recruitment Status : Completed
First Posted : October 19, 2021
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date October 5, 2021
First Posted Date October 19, 2021
Last Update Posted Date October 27, 2021
Actual Study Start Date June 3, 2020
Actual Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 5, 2021)		 Number of patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months [ Time Frame: Up to 6 months post brolucizumab injection ]
To assess IOI events observed after starting treatment with brolucizumab
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 5, 2021)
  • Age [ Time Frame: At the brolucizumab index date defined as the date of first brolucizumab injection ]
    Age information was reported
  • Gender information [ Time Frame: At the brolucizumab index date defined as the date of first brolucizumab injection ]
    Gender information was reported
  • Number of patients at various Patient Region [ Time Frame: At the brolucizumab index date defined as the date of first brolucizumab injection ]
    Patient regions: Northeast, Midwest, South, West, Unknown
  • Number of patients with Insurance type [ Time Frame: At the brolucizumab index date defined as the date of first brolucizumab injection ]
    Insurance type: Medicare, Medicare Advantage, Medicaid, Commercial, Government, Military, No Insurance, Miscellaneous, Unknown
  • Number of patients with Laterality of wet Age-related macular degeneration (AMD) [ Time Frame: At the brolucizumab index date defined as the date of first brolucizumab injection ]
    Laterality of wet AMD: Unilateral, Bilateral
  • Race/Ethnicity of the participants (patient level and eye level) [ Time Frame: At the brolucizumab index date defined as the date of first brolucizumab injection ]
    Caucasian, Black or African American, Asian, Other, Unknown
  • Number of eyes with the concurrent eye disease [ Time Frame: Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) ]
    Types of concurrent eye diseases: ▪ Cataracts
    • Posterior vitreous detachment
    • Puckering of macula
    • Macular hole
    • Vitreomacular traction
    • Glaucoma
    • Amblyopia
    • Papillitis
    • Ischemic optic atrophy
    • Diabetic retinopathy
    • Diabetic macular edema
    • Hypertensive retinopathy
    • Pathologic myopia
    • RAO
    • RO
    • RV
    • Vitritis
    • Endophthalmitis
    • Uveitis
    • Choroidal neovascularization (due to causes other than AMD, if possible, to determine)
    • IOI
  • Number of patient eyes with cataract status [ Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) ]
    Types: phakic, pseudophakic, aphakic
  • Number of patient eyes with Concomitant ocular medications [ Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) ]
    Types:
    • Corticosteroids
    • Prednisone
    • Prednisolone acetate
    • Difluprednate
    • Biologics
    • Cyclosporine
    • Methotrexate
    • Ganciclovir
    • Acyclovir
    • Trifluridine
    • Rituxan
  • Number of patient eyes with the history of ocular inflammation [ Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) ]
    The following categories were reported:
    • No history of inflammation
    • History of any ocular inflammation
    • History of severe ocular inflammation
    • History of anterior inflammation
    • History of posterior inflammation
    • History of IOI or endophthalmitis due to infections and other underlying disease (separate category)
  • Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO) [ Time Frame: 12 months prior to the index date ( index date defined as the date of first brolucizumab injection) ]
    Included history of ocular inflammation or occlusion
  • Number of patient eyes with the Provider specialty [ Time Frame: At the brolucizumab index date defined as the date of first brolucizumab injection ]
    The following types were included: Retina specialist, General ophthalmologist, Non-retina specialist, unknown
  • Number of patient eyes with the previous ocular surgeries or procedures [ Time Frame: 6 months prior to the index date ( index date defined as the date of first brolucizumab injection) ]
    The following categories were included:
    • Laser therapy
    • Laser coagulation
    • Photodynamic therapy
    • IOP lowering surgeries (lasers, glaucoma filtering, non-filtering glaucoma)
    • Cataract surgery
    • Iridotomy
    • Intraocular or refractive surgery (almost all IOP & cataract surgeries)
    • Previous penetrating keratoplasty, vitrectomy, or ocular radiation
    • Previous panretinal photocoagulation
    • Previous submacular surgery, other surgical intervention or laser treatment for AMD
  • Number of eyes treated with brolucizumab [ Time Frame: At the brolucizumab index date defined as the date of first brolucizumab injection ]
    The following types were included: OD [eye, right], OS [eye, left], Unspecified, Unilateral, Bilateral)
  • Number of patient eyes with Visual Acuity (VA) reading [ Time Frame: At the brolucizumab index date defined as the date of first brolucizumab injection with lookback of 365 days ]
    The following categories were included:
    • Snellen: 20/10, 20/12-20/20, 20/25-20/40, 20/50-20/160, ≤20/200
    • Approximate ETDRS letters
  • Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated [ Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) ]
    Anti-VEGF treatment-naive vs prior-treated were measured at the eye level
  • Number of patient eyes with the prior treatment status [ Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) ]
    The following types were included: off-label bevacizumab, ranibizumab, aflibercept, unknown, treatment-naive
  • Number of different prior anti-VEGF agents [ Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) ]
    The following categories were measured at the eye level: 0, 1, 2, ≥3
  • Number of prior anti-VEGF injections [ Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) ]
    Total, per anti-VEGF agent were measured at the eye level)
    • Continuous
    • Categorical: <6, 6 to <12, 12 to <24, ≥24
  • Duration of last anti-VEGF treatment [ Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) ]
    Total, per anti-VEGF agent; will be measured at the eye level
    • All anti-VEGFs i. Continuous ii. Categorical: <6, 6 to <12, 12 to <24, ≥24 months
    • Specific anti-VEGF iii. Continuous iv. Categorical: <6, 6 to <12, 12 to <24, ≥24 months
  • Time since wet Age-related macular degeneration (AMD) diagnosis [ Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) ]
    Patients were measured at the eye level
  • Time since any Age-related macular degeneration (AMD) diagnosis [ Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) ]
    Patients were measured at the eye level
  • Time from last anti-VEGF injection to index date (among switchers) [ Time Frame: At the brolucizumab index date defined as the date of first brolucizumab injection ]
    The following categories were measured:
    • Continuous (days)
    • Categorical (0-30, 31-60, 61-90, 91+ days)
  • Number of ocular adverse events (AEs) [ Time Frame: Post-index period defined as the 180 days following therapy initiation, excluding index date ]
    To assess the incidence of ocular AEs among patients treated with brolucizumab
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)
Official Title Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)
Brief Summary This study was a retrospective cohort study of patients to assess the early insights into real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to describe their patient characteristics and clinical outcomes. The study was conducted using the IRIS Registry.
Detailed Description

IRIS Registry EHR data from patients with wet AMD who initiated brolucizumab were analyzed in this study.

Identification period of the index date (index period): The patients fulfilling the selection criteria was identified

  • Index date: Defined as the date of the earliest brolucizumab injection
  • Study Period: The period from the first patient eye exposure to brolucizumab to the last follow-up recorded
  • Pre-index period: The period 36 months prior to the index date. Data within 36 months prior to the index date will be used to assess baseline characteristics.
  • Post-index period: The period 180 days after the index date
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with wet AMD who initiated brolucizumab were analyzed in this study.
Condition Age-related Macular Degeneration (AMD)
Intervention Drug: Brolucizumab
Participants received brolucizumab injection during the index period
Other Name: BEOVU®
Study Groups/Cohorts Brolucizumab
Participants received brolucizumab injection during the index period
Intervention: Drug: Brolucizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 5, 2021)		 9456
Original Actual Enrollment Same as current
Actual Study Completion Date December 15, 2020
Actual Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or EMR note for treatment with brolucizumab during the index period (date of earliest code or EMR note = index date)
  2. ≥18 years old on the index date
  3. ≥1 Current Procedural Terminology (CPT) code for intravitreal administration on the index date

  4. ≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in the 36 months prior to or on the index date

    o Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US.

  5. ≥1 follow-up visit after the index date
  6. ≥1 VA assessment on the index date or within 90 days prior to the index date

Exclusion Criteria:

  1. Use of brolucizumab prior to 10/8/2019 (e.g. clinical trials)
  2. Unknown laterality of the index eye on the index date
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05082415
Other Study ID Numbers CRTH258AUS15
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor Novartis Pharmaceuticals
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date October 2021