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

Age-related Macular Degeneration (AMD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05111743
• Other study ID #: CRTH258AUS21
• Status: Completed
• Start date: June 17, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: December 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 9261
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion criteria:

1. =1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or National Drug Code (NDC) for treatment with brolucizumab during the index period (date of earliest code = index date)

2. =18 years old on the index date

3. =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

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

4. =24 months of continuous enrollment prior to the index date

5. =1 follow-up visit related to their wet AMD after the index date

Exclusion criteria:

1. Use of brolucizumab prior to 08-Oct-2019 (e.g. clinical trials)

2. Unknown laterality of the index eye on the index date

3. Patients with no data throughout the 12 months immediately prior to the index date

Related Conditions & MeSH terms

• Age-related Macular Degeneration (AMD)
• Macular Degeneration

Intervention

Drug:
• Brolucizumab
Participants received brolucizumab injection during the index period

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 6 months post brolucizumab injection
Secondary	Age	Age information was reported	Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
Secondary	Gender information	Gender information was reported	Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
Secondary	Number of patients at various Patient Region	Patient regions: Northeast, Midwest, South, West, Unknown	Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
Secondary	Number of patients with Insurance type	Insurance type: Private, Medicare, Medicare Advantage, Medicaid, Other	Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
Secondary	Number of patients with Laterality of wet Age-related macular degeneration (AMD)	Laterality of wet AMD: Unilateral, Bilateral	Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
Secondary	Number of patients with Laterality of any Age-related macular degeneration (AMD)	Laterality of wet AMD: Unilateral, Bilateral	Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
Secondary	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	Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Secondary	Number of patient eyes with previous ocular surgeries or procedures	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; Cryopexy	Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Secondary	Number of patient eyes with systemic comorbidities	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 disease	36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Secondary	Number of Concomitant systemic medications (chronic use)	Types: Corticosteroids; Systemic anti-VEGFs; Lipid lowering agents; Antihypertensives; Biologics; Antimetabolites/cancer therapy; Anticoagulants	36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Secondary	Number of patient eyes with the Cataract status	Types: phakic, pseudophakic, aphakic	36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Secondary	Number of patient eyes with Intraocular inflammation	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 panuveitis	12 and 6 months prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Secondary	Number of patient eyes with the history of ocular inflammation (includes IOIs or panuveitis or endophthalmitis relevant to safety evaluation)	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 Panuveitis	36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Secondary	History of other IOI and endophthalmitis due to infections or other underlying disease	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)	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)
Secondary	Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO)	Included history of ocular inflammation or occlusion	12 months prior to the index date ( index date defined as the date of first brolucizumab injection)
Secondary	Number of patient eyes with Systemic inflammation / auto-immune history (in total and at the event level)	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)	36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Secondary	Number of patient eyes with the Provider specialty	The following types were included: Retina specialist, General ophthalmologist, Non-retina specialist, unknown	Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
Secondary	Number of patient eyes with Concomitant ocular medications	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	36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Secondary	Type of exam performed	OCT, FA, CP - color photo or color fundus photo	30 days before or on first brolucizumab injection (index date)
Secondary	Number of eyes treated with brolucizumab	The following types were included: OD [eye, right], OS [eye, left], Unspecified, Unilateral, Bilateral)	Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
Secondary	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	60 months prior to index ( index date defined as the date of first brolucizumab injection)
Secondary	Number of patient eyes with prior treatment status	The following types were included: off-label bevacizumab, ranibizumab, aflibercept, unknown, treatment-naive	60 months prior to index ( index date defined as the date of first brolucizumab injection)
Secondary	Number of patient eyes with different prior anti-VEGF agents	Following categories will be included : 0, 1, 2, =3	60 months prior to index ( index date defined as the date of first brolucizumab injection)
Secondary	Number of patient eyes with prior anti-VEGF agents (total, per anti-VEGF agent)	Following categories will be included : Continuous; Categorical: <6, 6 to <12, 12 to <24, =24	60 months prior to index ( index date defined as the date of first brolucizumab injection)
Secondary	Number of patient eyes with the Last injection inetrval	Following categories will be included : Continuous (weeks); Categorical: <4, 4 to <6, 6 to <8, =8, <12, =12 weeks	60 months prior to index ( index date defined as the date of first brolucizumab injection)
Secondary	Duration of last anti-VEGF treatment (total, per anti-VEGF agent)	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)	60 months prior to index ( index date defined as the date of first brolucizumab injection)
Secondary	Time since wet Age-related macular degeneration (AMD) diagnosis	Patients were measured at the eye level	36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Secondary	Time since any Age-related macular degeneration (AMD) diagnosis	Patients were measured at the eye level	36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Secondary	Time from last anti-VEGF injection to index date	The following categories were measured: Continuous (days); Categorical (0-30, 31-60, 61-90, 91+ days)	60 months prior to index ( index date defined as the date of first brolucizumab injection)
Secondary	Number of ocular adverse events (AEs)	To assess the incidence of ocular AEs among patients treated with brolucizumab	Post-index period defined as the 180 days following therapy initiation, excluding index date

External Links

•   Results for CRTH258AUS21 from the Novartis Clinical Trials Website