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

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) (IRIS Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05082415
• Other study ID #: CRTH258AUS15
• Status: Completed
• Start date: June 3, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: October 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 IRIS Registry.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9456
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 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 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

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 Pharmaceuticals	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	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	Gender information	Gender information was reported	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	Number of patients at various Patient Region	Patient regions: Northeast, Midwest, South, West, Unknown	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	Number of patients with Insurance type	Insurance type: Medicare, Medicare Advantage, Medicaid, Commercial, Government, Military, No Insurance, Miscellaneous, Unknown	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	Number of patients with Laterality of wet Age-related macular degeneration (AMD)	Laterality of wet AMD: Unilateral, Bilateral	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	Race/Ethnicity of the participants (patient level and eye level)	Caucasian, Black or African American, Asian, Other, Unknown	At the brolucizumab index date defined as the date of first brolucizumab injection
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 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 Concomitant ocular medications	Types: Corticosteroids; Prednisone; Prednisolone acetate; Difluprednate; Biologics; Cyclosporine; Methotrexate; Ganciclovir; Acyclovir; Trifluridine; Rituxan	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 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)	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 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 the Provider specialty	The following types were included: Retina specialist, General ophthalmologist, Non-retina specialist, unknown	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	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	6 months prior to the index date ( index date defined as the date of first brolucizumab injection)
Secondary	Number of eyes treated with brolucizumab	The following types were included: OD [eye, right], OS [eye, left], Unspecified, Unilateral, Bilateral)	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	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	At the brolucizumab index date defined as the date of first brolucizumab injection with lookback of 365 days
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	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 prior treatment status	The following types were included: off-label bevacizumab, ranibizumab, aflibercept, unknown, treatment-naive	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 different prior anti-VEGF agents	The following categories were measured at the eye level: 0, 1, 2, =3	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 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	36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Secondary	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	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 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 (among switchers)	The following categories were measured: Continuous (days); Categorical (0-30, 31-60, 61-90, 91+ days)	At the brolucizumab 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 CRTH258AUS15 from the Novartis Clinical Trials Website