- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05111743
Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New Jersey
-
East Hanover, New Jersey, United States, 79361080
- Novartis Investigative Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- ≥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)
- ≥18 years old on the index date
≥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
- ≥24 months of continuous enrollment prior to the index date
- ≥1 follow-up visit related to their wet AMD after the index date
Exclusion criteria:
- Use of brolucizumab prior to 08-Oct-2019 (e.g. clinical trials)
- Unknown laterality of the index eye on the index date
- Patients with no data throughout the 12 months immediately prior to the index date
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Brolucizumab
Participants received brolucizumab injection during the index period
|
Participants received brolucizumab injection during the index period
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months
Time Frame: Up to 6 months post brolucizumab injection
|
To assess IOI events observed after starting treatment with brolucizumab
|
Up to 6 months post brolucizumab injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO)
Time Frame: 12 months prior to the index date ( index date defined as the date of first brolucizumab injection)
|
Included history of ocular inflammation or occlusion
|
12 months prior to the index date ( index date defined as the date of first brolucizumab injection)
|
Time since wet Age-related macular degeneration (AMD) diagnosis
Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
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)
|
Time since any Age-related macular degeneration (AMD) diagnosis
Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
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)
|
Number of ocular adverse events (AEs)
Time Frame: Post-index period defined as the 180 days following therapy initiation, excluding index date
|
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
|
Age
Time Frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
|
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)
|
Gender information
Time Frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
|
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)
|
Number of patients at various Patient Region
Time Frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
|
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)
|
Number of patients with Insurance type
Time Frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
|
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)
|
Number of patients with Laterality of wet Age-related macular degeneration (AMD)
Time Frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
|
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)
|
Number of patients with Laterality of any Age-related macular degeneration (AMD)
Time Frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
|
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)
|
Number of eyes with the concurrent eye disease
Time Frame: Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
Types of concurrent eye diseases:
|
Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
Number of patient eyes with previous ocular surgeries or procedures
Time Frame: Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
Types:
|
Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
Number of patient eyes with systemic comorbidities
Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
Types:
|
36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
Number of Concomitant systemic medications (chronic use)
Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
Types:
|
36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
Number of patient eyes with the Cataract status
Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
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)
|
Number of patient eyes with Intraocular inflammation
Time Frame: 12 and 6 months prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
The following categories were reported:
|
12 and 6 months prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
Number of patient eyes with the history of ocular inflammation (includes IOIs or panuveitis or endophthalmitis relevant to safety evaluation)
Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
The following categories were reported:
|
36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
History of other IOI and endophthalmitis due to infections or other underlying disease
Time Frame: 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)
|
The following categories were reported:
|
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)
|
Number of patient eyes with Systemic inflammation / auto-immune history (in total and at the event level)
Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
The following categories were reported:
|
36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
Number of patient eyes with the Provider specialty
Time Frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
|
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)
|
Number of patient eyes with Concomitant ocular medications
Time Frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
|
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)
|
Type of exam performed
Time Frame: 30 days before or on first brolucizumab injection (index date)
|
OCT, FA, CP - color photo or color fundus photo
|
30 days before or on first brolucizumab injection (index date)
|
Number of eyes treated with brolucizumab
Time Frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
|
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)
|
Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated
Time Frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
|
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)
|
Number of patient eyes with prior treatment status
Time Frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
|
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)
|
Number of patient eyes with different prior anti-VEGF agents
Time Frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
|
Following categories will be included : 0, 1, 2, ≥3
|
60 months prior to index ( index date defined as the date of first brolucizumab injection)
|
Number of patient eyes with prior anti-VEGF agents (total, per anti-VEGF agent)
Time Frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
|
Following categories will be included :
|
60 months prior to index ( index date defined as the date of first brolucizumab injection)
|
Number of patient eyes with the Last injection inetrval
Time Frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
|
Following categories will be included :
|
60 months prior to index ( index date defined as the date of first brolucizumab injection)
|
Duration of last anti-VEGF treatment (total, per anti-VEGF agent)
Time Frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
|
Following categories will be included :
|
60 months prior to index ( index date defined as the date of first brolucizumab injection)
|
Time from last anti-VEGF injection to index date
Time Frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
|
The following categories were measured:
|
60 months prior to index ( index date defined as the date of first brolucizumab injection)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRTH258AUS21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Age-related Macular Degeneration (AMD)
-
AbbVieAbbVieEnrolling by invitationGene Therapy | AMD | nAMD | Wet AMD | Neovascular Age-Related Macular Degeneration (nAMD) | wAMDUnited States
-
Moorfields Eye Hospital NHS Foundation TrustMedical Research CouncilCompletedAge Related Macular Degeneration (AMD)
-
Novartis PharmaceuticalsCompleted
-
Novartis PharmaceuticalsCompletedAge-related Macular Degeneration (AMD)United States
-
University Hospital, LimogesUnknownAge-related Macular Degeneration (AMD)France
-
National Eye Institute (NEI)Completed
-
Pfenex, IncCompletedAge Related Macular Degeneration (AMD)New Zealand
-
VA Office of Research and DevelopmentAugusta UniversityNot yet recruitingAge-related Macular Degeneration (AMD)United States
-
Alcon ResearchNovartis Institutes for BioMedical ResearchTerminatedAge-related Macular Degeneration (AMD)United States
-
Newtricious R&D BVSprim Advanced Life SciencesCompletedAge-related Macular Degeneration (AMD)United States, Germany, Netherlands, United Kingdom
Clinical Trials on Brolucizumab
-
Novartis PharmaceuticalsNot yet recruiting
-
Novartis PharmaceuticalsTerminatedNeovascular Age-related Macular DegenerationUnited Kingdom
-
Novartis PharmaceuticalsActive, not recruitingDiabetic Macular Edema (DME) | Neovascular Age-related Macular Degeneration (nAMD)Germany
-
Novartis PharmaceuticalsActive, not recruitingNeovascular Age-related Macular Degeneration (nAMD)Portugal
-
Novartis PharmaceuticalsRecruitingNeovascular Age-related Macular DegenerationUnited Arab Emirates
-
Novartis PharmaceuticalsWithdrawn
-
Novartis PharmaceuticalsCompletedAge-related Macular DegenerationGermany, Switzerland
-
Novartis PharmaceuticalsActive, not recruitingDiabetic Macular EdemaJapan
-
Novartis PharmaceuticalsRecruitingNeovascular Age-related Macular DegenerationKorea, Republic of
-
Novartis PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States