An observational study in Age-related Macular Degeneration (AMD), sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-10-27.
Sponsored by Novartis Pharmaceuticals · Observational
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.
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
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 9,456 is above the median of 106 across 421 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with wet AMD who initiated brolucizumab were analyzed in this study.
≥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.
Exclusion Criteria:
Participants received brolucizumab injection during the index period
Drug: Brolucizumab
Participants received brolucizumab injection during the index period
Also known as: BEOVU®
Number of patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months
To assess IOI events observed after starting treatment with brolucizumab
Time frame: Up to 6 months post brolucizumab injection
Age
Age information was reported
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Gender information
Gender information was reported
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patients at various Patient Region
Patient regions: Northeast, Midwest, South, West, Unknown
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patients with Insurance type
Insurance type: Medicare, Medicare Advantage, Medicaid, Commercial, Government, Military, No Insurance, Miscellaneous, Unknown
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patients with Laterality of wet Age-related macular degeneration (AMD)
Laterality of wet AMD: Unilateral, Bilateral
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Race/Ethnicity of the participants (patient level and eye level)
Caucasian, Black or African American, Asian, Other, Unknown
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of eyes with the concurrent eye disease
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
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)
Number of patient eyes with cataract status
Types: phakic, pseudophakic, aphakic
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)
Number of patient eyes with Concomitant ocular medications
Types: * Corticosteroids * Prednisone * Prednisolone acetate * Difluprednate * Biologics * Cyclosporine * Methotrexate * Ganciclovir * Acyclovir * Trifluridine * Rituxan
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)
Number of patient eyes with the history of ocular inflammation
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)
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)
Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO)
Included history of ocular inflammation or occlusion
Time frame: 12 months prior to the index date ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with the Provider specialty
The following types were included: Retina specialist, General ophthalmologist, Non-retina specialist, unknown
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patient eyes with the previous ocular surgeries or procedures
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
Time frame: 6 months prior to the index date ( index date defined as the date of first brolucizumab injection)
Number of eyes treated with brolucizumab
The following types were included: OD \[eye, right\], OS \[eye, left\], Unspecified, Unilateral, Bilateral)
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patient eyes with Visual Acuity (VA) reading
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
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection with lookback of 365 days
Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated
Anti-VEGF treatment-naive vs prior-treated were measured at the eye level
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)
Number of patient eyes with the prior treatment status
The following types were included: off-label bevacizumab, ranibizumab, aflibercept, unknown, treatment-naive
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)
Number of different prior anti-VEGF agents
The following categories were measured at the eye level: 0, 1, 2, ≥3
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)
Number of prior anti-VEGF injections
Total, per anti-VEGF agent were measured at the eye level) * Continuous * Categorical: \<6, 6 to \<12, 12 to \<24, ≥24
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)
Duration of last anti-VEGF treatment
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 frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Time since wet Age-related macular degeneration (AMD) diagnosis
Patients were measured at the eye level
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)
Time since any Age-related macular degeneration (AMD) diagnosis
Patients were measured at the eye level
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)
Time from last anti-VEGF injection to index date (among switchers)
The following categories were measured: * Continuous (days) * Categorical (0-30, 31-60, 61-90, 91+ days)
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of ocular adverse events (AEs)
To assess the incidence of ocular AEs among patients treated with brolucizumab
Time frame: Post-index period defined as the 180 days following therapy initiation, excluding index date
Plan to share: No
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Novartis Pharmaceuticals