Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Brolucizumab Participants received brolucizumab injection during the index period |
Drug: Brolucizumab
Participants received brolucizumab injection during the index period
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months [Up to 4 months post brolucizumab injection]
To describe anti-VEGF treatment status (naive or switcher) in patients with wet AMD who initiated brolucizumab
Secondary Outcome Measures
- Age information [Index date]
Age information was reported
- Gender information [Index date]
Gender information was reported
- Number of participants: Regions [12-month period prior to index]
Northeast, North Central, South, West, Unknown
- Number of participants: Insurance type [12-month period prior to index]
Private, Medicare, Medicare Advantage, Medicaid, Other
- Number of participants: Laterality [12-month period prior to index]
Unilateral, Bilateral
- Number of participants: Race [12-month period prior to index]
White, African American, Asian
- Number of participants: Concurrent eye disease [12-month period prior to index]
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
- Number of participants: Provider specialty [At the brolucizumab index date defined as the date of first brolucizumab injection]
Participants were categorized based on provider specialty at date of first brolucizumab injection (e.g. Retina specialist, Ophthalmologist, etc)
- Encounter location (practice location) [At the brolucizumab index date defined as the date of first brolucizumab injection]
Midwest, Northeast, South, West, Unknown
- Eye location of brolucizumab injections [12-month period prior to index]
e.g. OD [eye, right], OS [eye, left], Unspecified
- Index Visual acuity (VA) [At the brolucizumab index date defined as the date of first brolucizumab injection]
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
- Wet AMD diagnosis for the fellow eye [At the brolucizumab index date defined as the date of first brolucizumab injection]
Wet AMD diagnosis for the fellow eye as of the index date (Yes/No)
- Visual acuity of the fellow eye [At the brolucizumab index date defined as the date of first brolucizumab injection]
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
- Number of prior anti-VEGF treatments [12-month period prior to index]
Number of anti-VEGF treatments used prior to brolucizumab at index by number of eyes were reported
- Type of prior anti-VEGF treatment among switchers to brolucizumab [12-month period prior to index]
Type of anti-VEGF agent (aflibercept, bevacizumab, ranibizumab, unlicensed bevacizumab) used immediately prior to index were reported
- Prior anti-VEGF treatment sequence [12-month period prior to index]
Prior treatment sequence(s) for previously treated eyes were reported. Continuous or Categorical (aflibercept, bevacizumab and ranibizumab)
- Number of prior anti-VEGF injections received prior to brolucizumab index date [12-month period prior to index]
Total and Per treatment prior anti-VEGF injections received prior to brolucizumab index date were reported
- Injection intervals for the eyes that had received anti-VEGF injections prior to index [12-month period prior to index]
Last injection interval, Average of last two injection intervals and Average of last three injection intervals were reported
- Anti-VEGF treatment status for the fellow eye [At the brolucizumab index date defined as the date of first brolucizumab injection]
Anti-VEGF treatment endpoints for the fellow eyes with wet AMD (Naive, Switcher) were reported
- Type of treatment for the fellow eye [At the brolucizumab index date defined as the date of first brolucizumab injection]
Following type of treatment for the fellow eye will be reported: aflibercept, bevacizumab, ranibizumab, brolucizumab, unlicensed bevacizumab, or none)
- The number of prior anti-VEGF treatments for the fellow eye [At the brolucizumab index date defined as the date of first brolucizumab injection]
Number of prior anti-VEGF injections for the fellow eye will be reported: Continuous or Categorical (e.g. 0, 1, ≥2)
- Number of brolucizumab injections received per study eye [Up to 4 months post index date]
Early treatment patterns after brolucizumab index date in anti-VEGF switcher and anti-VEGF naive patient eyes were reported
- The last injection interval [Up to 4 months post index date]
The length of the interval between the final two injections was reported
- The first injection interval after switch compared to last injection interval with a prior treatment [Up to 4 months post index date]
Longer, same or shorter interval were reported
- Type of anti-VEGF agent initiated after switching from index brolucizumab [First 3 months after switching from index brolucizumab]
Thr type of anti-VEGF agent initiated in the first 3 months after switching from index brolucizumab. were reported
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigational site | East Hanover | New Jersey | United States | 07936-1080 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CRTH258AUS12