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
NCT number | NCT05037396 |
Other study ID # | CRTH258AUS12 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 5, 2020 |
Est. completion date | August 1, 2020 |
Verified date | October 2021 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Novartis Investigational site | East Hanover | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States,
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 |
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