Clinical trial NCT05082415: Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)
Official title: Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration (AMD)
Keywords: Brolucizumab,
intravitreal injection,
neovascular age-related macular degeneration,
visual acuity
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 9456
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with wet AMD who initiated brolucizumab were analyzed in this study.

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 IRIS Registry.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months
timeFrame: Up to 6 months post brolucizumab injection
Secondary outcomes:
measure: Age
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Gender information
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Number of patients at various Patient Region
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Number of patients with Insurance type
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Number of patients with Laterality of wet Age-related macular degeneration (AMD)
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Race/Ethnicity of the participants (patient level and eye level)
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Number of eyes with the concurrent eye disease
timeFrame: Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with cataract status
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with Concomitant ocular medications
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with the history of ocular inflammation
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO)
timeFrame: 12 months prior to the index date ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with the Provider specialty
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Number of patient eyes with the previous ocular surgeries or procedures
timeFrame: 6 months prior to the index date ( index date defined as the date of first brolucizumab injection)
measure: Number of eyes treated with brolucizumab
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Number of patient eyes with Visual Acuity (VA) reading
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection with lookback of 365 days
measure: Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with the prior treatment status
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of different prior anti-VEGF agents
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of prior anti-VEGF injections
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Duration of last anti-VEGF treatment
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Time since wet Age-related macular degeneration (AMD) diagnosis
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Time since any Age-related macular degeneration (AMD) diagnosis
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Time from last anti-VEGF injection to index date (among switchers)
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Number of ocular adverse events (AEs)
timeFrame: Post-index period defined as the 180 days following therapy initiation, excluding index date
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: