Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab
- Registration Number
- NCT05037396
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9457
- 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
- There were no exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Brolucizumab Brolucizumab Participants received brolucizumab injection during the index period
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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: 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 worseNumber of participants: Race 12-month period prior to index White, African American, Asian
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 worseNumber 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
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
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
Trial Locations
- Locations (1)
Novartis Investigational site
🇺🇸East Hanover, New Jersey, United States