Age-related Macular Degeneration (AMD)
Conditions
Keywords
Brolucizumab,, intravitreal injection,, neovascular age-related macular degeneration,, visual acuity
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
Interventions
DRUGBrolucizumab
Participants received brolucizumab injection during the index period
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) * IOI |
| Number 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 * Rituxan |
| Number 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, unknown |
| 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 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 letters |
| Number 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-naive |
| Number 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, ≥3 |
| Number 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, ≥24 |
| Duration 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 |
| 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 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 |
| Number 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 AMD |
Countries
United States
Outcome results
None listed