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

Age-related Macular Degeneration (AMD) Clinical Trial

Official title:

Treatment History, Demographic Characteristics, Clinical Characteristics, and Early Treatment Patterns of Patients Who Received Brolucizumab for Neovascular Age-related Macular Degeneration: IRIS Registry Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05037396
• Other study ID #: CRTH258AUS12
• Status: Completed
• Start date: March 5, 2020
• Est. completion date: August 1, 2020

Study information

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

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9457
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

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 Investigational 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 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	Up to 4 months post brolucizumab injection
Secondary	Age information	Age information was reported	Index date
Secondary	Gender information	Gender information was reported	Index date
Secondary	Number of participants: Regions	Northeast, North Central, South, West, Unknown	12-month period prior to index
Secondary	Number of participants: Insurance type	Private, Medicare, Medicare Advantage, Medicaid, Other	12-month period prior to index
Secondary	Number of participants: Laterality	Unilateral, Bilateral	12-month period prior to index
Secondary	Number of participants: Race	White, African American, Asian	12-month period prior to index
Secondary	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	12-month period prior to index
Secondary	Number of participants: Provider specialty	Participants were categorized based on provider specialty at date of first brolucizumab injection (e.g. Retina specialist, Ophthalmologist, etc)	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	Encounter location (practice location)	Midwest, Northeast, South, West, Unknown	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	Eye location of brolucizumab injections	e.g. OD [eye, right], OS [eye, left], Unspecified	12-month period prior to index
Secondary	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	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	Wet AMD diagnosis for the fellow eye	Wet AMD diagnosis for the fellow eye as of the index date (Yes/No)	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	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	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	Number of prior anti-VEGF treatments	Number of anti-VEGF treatments used prior to brolucizumab at index by number of eyes were reported	12-month period prior to index
Secondary	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	12-month period prior to index
Secondary	Prior anti-VEGF treatment sequence	Prior treatment sequence(s) for previously treated eyes were reported. Continuous or Categorical (aflibercept, bevacizumab and ranibizumab)	12-month period prior to index
Secondary	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	12-month period prior to index
Secondary	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	12-month period prior to index
Secondary	Anti-VEGF treatment status for the fellow eye	Anti-VEGF treatment endpoints for the fellow eyes with wet AMD (Naive, Switcher) were reported	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	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)	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	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)	At the brolucizumab index date defined as the date of first brolucizumab injection
Secondary	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	Up to 4 months post index date
Secondary	The last injection interval	The length of the interval between the final two injections was reported	Up to 4 months post index date
Secondary	The first injection interval after switch compared to last injection interval with a prior treatment	Longer, same or shorter interval were reported	Up to 4 months post index date
Secondary	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	First 3 months after switching from index brolucizumab

External Links

•   Results for CRTH258AUS12 from the Novartis Clinical Trials Website