Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab

Novartis Pharmaceuticals9,457 enrolled

Overview

This was a retrospective cohort study to assess the treatment history, demographic characteristics, clinical characteristics, and early treatment patterns of patients who received brolucizumab for neovascular age-related macular degeneration using IRIS Registry.

This was a retrospective cohort study of patients with wet AMD who received brolucizumab. Evidence was generated from the IRIS registry to describe patient treatment histories, demographic and clinical characteristics, and early treatment patterns. Setting and study population: IRIS Registry EHR data from 10/08/2018 to the 03/31/2020 from patients with wet AMD who initiated brolucizumab were analyzed. Identification period of the index date: The patients fulfilling the selection criteria identified during the period from 10/08/2019 to 03/31/2020. Index date: Defined as the date of the earliest brolucizumab injection. Study Period: The period from 10/08/2018 to 03/31/2020. Pre-index period: The period 12 months prior to the index date. Post-index period: The period 4 months after the index date (not a required selection criterion; only for the assessment of select endpoints in a subgroup of patients).

Study Type

OBSERVATIONAL

Enrollment

9,457

Conditions

Age-related Macular Degeneration (AMD)

Interventions

BrolucizumabDRUG

Participants received brolucizumab injection during the index period

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with ≥1 brolucizumab injection * Diagnosis of wet AMD (ICD-10: H35.3210, H35.3211, H35.3212, H35.3213, H35.3220, H35.3221, H35.3222, H35.3223, H35.3230, H35.3231, H35.3232, H35.3233, H35.3290, H35.3291, H35.3292, and H35.3293) on the index date Exclusion Criteria: * There were no exclusion criteria

Locations (1)

Novartis Investigational site

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months

To describe anti-VEGF treatment status (naive or switcher) in patients with wet AMD who initiated brolucizumab

Time frame: Up to 4 months post brolucizumab injection

Secondary Outcomes

Age information

Age information was reported

Time frame: Index date

Gender information

Gender information was reported

Time frame: Index date

Number of participants: Regions

Northeast, North Central, South, West, Unknown

Time frame: 12-month period prior to index

Number of participants: Insurance type

Private, Medicare, Medicare Advantage, Medicaid, Other

Time frame: 12-month period prior to index

Number of participants: Laterality

Unilateral, Bilateral

Time frame: 12-month period prior to index

Number of participants: Race

White, African American, Asian

Time frame: 12-month period prior to index

Number of participants: Concurrent eye disease

Participants were measured at the eye level for the following eye diseases: Cataracts, Posterior vitreous detachment, Epiretinal membrane, Macular hole, Vitreomacular traction, Amblyopia, Pseudophakia, Glaucoma, Diabetic macular edema, Retinal vein occlusion, Diabetic retinopathy, Myopic choroidal neovascularization

Data from ClinicalTrials.gov

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Time frame: 12-month period prior to index

Number of participants: Provider specialty

Participants were categorized based on provider specialty at date of first brolucizumab injection (e.g. Retina specialist, Ophthalmologist, etc)

Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

Encounter location (practice location)

Midwest, Northeast, South, West, Unknown

Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

Eye location of brolucizumab injections

e.g. OD \[eye, right\], OS \[eye, left\], Unspecified

Time frame: 12-month period prior to index

Index Visual acuity (VA)

Visual acuity using Snellen and approximate Early Treatment Diabetic Retinopathy Study \[ETDRS\] letters). Snellen VA ranges: 20/12-20/20 20/25-20/40 20/50-20/160 20/200 or worse

Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

Wet AMD diagnosis for the fellow eye

Wet AMD diagnosis for the fellow eye as of the index date (Yes/No)

Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

Visual acuity of the fellow eye

Visual acuity using Snellen and approximate Early Treatment Diabetic Retinopathy Study \[ETDRS\] letters). Snellen VA ranges: 20/12-20/20 20/25-20/40 20/50-20/160 20/200 or worse

Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

Number of prior anti-VEGF treatments

Number of anti-VEGF treatments used prior to brolucizumab at index by number of eyes were reported

Time frame: 12-month period prior to index

Type of prior anti-VEGF treatment among switchers to brolucizumab

Type of anti-VEGF agent (aflibercept, bevacizumab, ranibizumab, unlicensed bevacizumab) used immediately prior to index were reported

Time frame: 12-month period prior to index

Prior anti-VEGF treatment sequence

Prior treatment sequence(s) for previously treated eyes were reported. Continuous or Categorical (aflibercept, bevacizumab and ranibizumab)

Time frame: 12-month period prior to index

Number of prior anti-VEGF injections received prior to brolucizumab index date

Total and Per treatment prior anti-VEGF injections received prior to brolucizumab index date were reported

Time frame: 12-month period prior to index

Injection intervals for the eyes that had received anti-VEGF injections prior to index

Last injection interval, Average of last two injection intervals and Average of last three injection intervals were reported

Time frame: 12-month period prior to index

Anti-VEGF treatment status for the fellow eye

Anti-VEGF treatment endpoints for the fellow eyes with wet AMD (Naive, Switcher) were reported

Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

Type of treatment for the fellow eye

Following type of treatment for the fellow eye will be reported: aflibercept, bevacizumab, ranibizumab, brolucizumab, unlicensed bevacizumab, or none)

Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

The number of prior anti-VEGF treatments for the fellow eye

Number of prior anti-VEGF injections for the fellow eye will be reported: Continuous or Categorical (e.g. 0, 1, ≥2)

Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

Number of brolucizumab injections received per study eye

Early treatment patterns after brolucizumab index date in anti-VEGF switcher and anti-VEGF naive patient eyes were reported

Time frame: Up to 4 months post index date

The last injection interval

The length of the interval between the final two injections was reported

Time frame: Up to 4 months post index date

The first injection interval after switch compared to last injection interval with a prior treatment

Longer, same or shorter interval were reported

Time frame: Up to 4 months post index date

Type of anti-VEGF agent initiated after switching from index brolucizumab

Thr type of anti-VEGF agent initiated in the first 3 months after switching from index brolucizumab. were reported

Time frame: First 3 months after switching from index brolucizumab