Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)
- Registration Number
- NCT05111743
- 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 Komodo Healthcare Map.
- Detailed Description
Komodo Healthcare Map claims data from 08-Oct-2016 to the date of most recent 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 were identified during the period from 08-Oct-2019 to 30-Apr-2020.
* Index date: Defined as the date of the earliest brolucizumab injection during the index period.
* Study Period: The period from 08-Oct-2016 to the most recent data extraction date (05-Jun-2020).
o Note since 05-Jun-2020 was the date data was pulled, claims data from recent months (e.g. May) may be incomplete (relative to the final DB state) as well.
* Pre-index period: The period 36 months prior to the index date
o Note: Data within 36 months prior to the index date will be used to assess baseline characteristics.
* Post-index period: The period of 180 days after the index date
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9261
Not provided
Not provided
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 Number of patient eyes with Intraocular inflammation 12 and 6 months 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 IOI and endophthalmitis related to safety evaluation and panuveitis
* History of IOI and endophthalmitis related to safety evaluation and panuveitis
* History of IOI including panuveitis (excluding endophthalmitis related to safety evaluation)
* History of endophthalmitis related to safety evaluation
* History of panuveitisNumber of patient eyes with the Provider specialty Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) The following types were included:
Retina specialist, General ophthalmologist, Non-retina specialist, unknownNumber of patient eyes with the Last injection inetrval 60 months prior to index ( index date defined as the date of first brolucizumab injection) Following categories will be included :
* Continuous (weeks)
* Categorical: \<4, 4 to \<6, 6 to \<8, ≥8, \<12, ≥12 weeksTime 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
Age Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) Age information was reported
Gender information Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) Gender information was reported
Number of patients at various Patient Region Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) Patient regions: Northeast, Midwest, South, West, Unknown
Number of patients with Laterality of wet Age-related macular degeneration (AMD) Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) 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)
* IOINumber of patients with Laterality of any Age-related macular degeneration (AMD) Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) Laterality of wet AMD: Unilateral, Bilateral
Number of patient eyes with previous ocular surgeries or procedures Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) Types:
* Laser photocoagulation (or laser therapy)
* Photodynamic therapy (PDT)
* Glaucoma surgery (trabeculectomy, MIGS)
* Cataract surgery
* Iridotomy
* Ocular radiation
* Panretinal photocoagulation
* Submacular surgery, other surgical intervention or laser treatment for AMD
* Vitrectomy
* Scleral buckle
* Pneumatic retinopexy
* CryopexyNumber 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 patients with Insurance type Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) Insurance type: Private, Medicare, Medicare Advantage, Medicaid, Other
Number of patient eyes with Systemic inflammation / auto-immune history (in total and at the event level) 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:
* Systemic vasculitis
* Rheumatoid arthritis
* SLE
* Multiple sclerosis
* Sarcoidosis
* Giant cell arteritis / Temporal arteritis
* HLA-B27 diseases
* Behcet/Behcet's disease
* Ankylosing Spondylitis
* Crohn Disease
* Drug Hypersensitivity
* Vogt-Koyanagi-Harada (VKH)Number of eyes treated with brolucizumab Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) The following types were included:
OD \[eye, right\], OS \[eye, left\], Unspecified, Unilateral, Bilateral)Time from last anti-VEGF injection to index date 60 months prior to index ( 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
History of other IOI and endophthalmitis due to infections or other underlying disease 36, 12 and 6 months 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 different prior anti-VEGF agents 60 months prior to index ( index date defined as the date of first brolucizumab injection) Following categories will be included : 0, 1, 2, ≥3
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
Number of patient eyes with systemic comorbidities 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) Types:
* Obesity
* Cerebrovascular disease
* Peripheral vascular disease
* Diabetes
* Renal disease
* Chronic pulmonary disease
* Congestive heart failure
* Any malignancy, including lymphoma and leukemia
* Myocardial infarction
* Dementia
* Arteriothrombotic event
* Thromboembolytic event
* Atherosclerosis
* Arterial hypertension
* Ischemic heart disease
* Atrial fibrillation
* Lipid disorders
* Cardiac septal defect
* Valvular cardiac defect
* Hyperlipidemia
* Hypercholesterolemia
* Atherosclerotic disease
* Thrombosis
* Carotid artery diseaseNumber of Concomitant systemic medications (chronic use) 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
* Systemic anti-VEGFs
* Lipid lowering agents
* Antihypertensives
* Biologics
* Antimetabolites/cancer therapy
* AnticoagulantsNumber of patient eyes with the 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 the history of ocular inflammation (includes IOIs or panuveitis or endophthalmitis relevant to safety evaluation) 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:
* History of anterior inflammation
* History of posterior inflammation
* No history of IOI or endophthalmitis related to safety evaluation or panuveitis
* History of IOI and/or endophthalmitis related to safety evaluation and/or panuveitis
* History of IOI including panuveitis (excluding endophthalmitis related to safety evaluation)
* History of endophthalmitis related to safety evaluation
* History of PanuveitisNumber of patient eyes with prior treatment status 60 months prior to index ( 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 patient eyes with prior anti-VEGF agents (total, per anti-VEGF agent) 60 months prior to index ( index date defined as the date of first brolucizumab injection) Following categories will be included :
* Continuous
* Categorical: \<6, 6 to \<12, 12 to \<24, ≥24Number 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) The following types were included: any corticosteroids \[prednisone, prednisolone acetate, difluprednate, Kenalog, ozurdex, yutiq\], biologics \[adalimumab\], cyclosporine, azathioprine, methotrexate, ganciclovir, acyclovir, valacyclovir, foscavir, trifluridine, mycophenolate, rituxan, vancomycin, prostaglandins
Type of exam performed 30 days before or on first brolucizumab injection (index date) OCT, FA, CP - color photo or color fundus photo
Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated 60 months prior to index ( index date defined as the date of first brolucizumab injection) Anti-VEGF treatment-naive vs prior-treated were measured at the eye-level
Duration of last anti-VEGF treatment (total, per anti-VEGF agent) 60 months prior to index ( index date defined as the date of first brolucizumab injection) Following categories will be included :
* All anti-VEGFs i. Continuous ii. Categorical: \<6, 6 to \<12, 12 to \<24, ≥24 months
* Specific anti-VEGF iii. Continuous (days)
Trial Locations
- Locations (1)
Novartis Investigative Site
🇺🇸East Hanover, New Jersey, United States