Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)
- Registration Number
- NCT05082415
- Lead Sponsor
- Novartis Pharmaceuticals
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9456
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≥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)
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≥18 years old on the index date
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≥1 Current Procedural Terminology (CPT) code for intravitreal administration on the index date
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≥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.
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≥1 follow-up visit after the index date
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≥1 VA assessment on the index date or within 90 days prior to the index date
- Use of brolucizumab prior to 10/8/2019 (e.g. clinical trials)
- Unknown laterality of the index eye on the index date
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Brolucizumab Brolucizumab Participants received brolucizumab injection during the index period
- Primary Outcome Measures
Name Time Method Number of patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months Up to 6 months post brolucizumab injection To assess IOI events observed after starting treatment with brolucizumab
- Secondary Outcome Measures
Name Time Method Age At the brolucizumab index date defined as the date of first brolucizumab injection Age information was reported
Gender information At the brolucizumab index date defined as the date of first brolucizumab injection Gender information was reported
Number of patients at various Patient Region 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 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) 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) 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 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)
* IOINumber of patient eyes with cataract status 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 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
* RituxanNumber of patient eyes with the history of ocular inflammation 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) 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 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, unknownNumber of patient eyes with the previous ocular surgeries or procedures 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 AMDNumber of ocular adverse events (AEs) 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
Time since wet Age-related macular degeneration (AMD) diagnosis 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 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) 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 eyes treated with brolucizumab 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 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 lettersNumber of patient eyes with Anti-VEGF treatment-naive vs prior-treated 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 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-naiveNumber of different prior anti-VEGF agents 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, ≥3Number of prior anti-VEGF injections 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, ≥24Duration of last anti-VEGF treatment 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
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States