An observational study in Age-related Macular Degeneration (AMD), sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-12-21.
Sponsored by Novartis Pharmaceuticals · Observational
In this cross-sectional study of patients with wet AMD who received ≥1 anti-VEGF injection (excluding brolucizumab), evidence was generated to describe the period prevalence of specific ocular AEs. The study was conducted using the IRIS Registry, and all results were based on the study period from 01/01/2019 to 12/31/2019.
This was a retrospective cohort study of eyes in adult patients with a diagnosis of wet AMD who were treated with anti-VEGF agents from 01/01/2019 to 12/31/2019.
IRIS Registry data from 01/01/2019 to 12/31/2019 for patients with a diagnosis of wet AMD who were treated with ≥1 anti-VEGF agent (excluding brolucizumab) were included.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 331,541 is above the median of 106 across 421 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
IRIS Registry data from 01/01/2019 to 12/31/2019 for patients with a diagnosis of wet AMD who were treated with ≥1 anti-VEGF agent (excluding brolucizumab) were included.
Exclusion Criteria:
Patients/patient eyes who were treated only with aflibercept in 2019
Other: Aflibercept
Patients/patient eyes who were treated only with ranibizumab in 2019
Other: Ranibizumab
Patients/patient eyes who were treated only with bevacizumab in 2019
Other: Bevacizumab
Patients/patient eyes who were treated with ≥2 different anti-VEGFs in 2019
intravitreal injection
Also known as: EYLEA®
intravitreal injection
Also known as: LUCENTIS®
intravitreal injection
Also known as: AVASTIN®; off-label use
Number of patients with Intraocular Inflammation (IOI) Adverse events (AEs) who were treated with anti-VEGF agents
Period prevalence of IOI in patients with wet AMD who were treated with anti- VEGF agents (excluding brolucizumab) over a one-year period in 2019 was assessed.
Time frame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Age
Age information was reported
Time frame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Gender information
Gender information was reported
Time frame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Number of patients at various Patient Region
Patient regions: Northeast, Midwest, South, West, Unknown
Time frame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Number of patients with Insurance type
Private, Medicare, Medicare Advantage, Medicaid, Other
Time frame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Number of patients with Laterality of wet Age-related macular degeneration (AMD)
Laterality of wet AMD: Unilateral, Bilateral
Time frame: Index date (defined as the date of first injection - 01/01/2019)
Number of patient eyes with the Provider specialty on date of first anti-VEGF injection
The following types were included: Retina specialist, General ophthalmologist
Time frame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Number of patient eyes treated with anti-VEGF agent
The following types were included OD \[eye, right\], OS \[eye, left\], Unspecified
Time frame: Index date (defined as the date of first injection - 01/01/2019)
Number of anti-VEGF injections
Anti-VEGF utilization in patients with wet AMD who were treated with anti- VEGF agents (excluding brolucizumab) over a one-year period was assessed. Measured at the patient level and patient-eye level.
Time frame: over a one-year period from 01/012019 to 31/12/2019
Number of patients with other ocular AEs in patients with wet AMD who were treated with anti-VEGF agents (excluding brolucizumab)
The following types were included: 1. Key ocular AEs 2. IOI events 3. RVO events 4. Unspecified RO 5. Autoimmune disorders (systemic lupus erythematosus \[SLE\], Behcet's disease, sarcoidosis, VKH disease, HLA-B27 syndromes, Drug hypersensitivity) 6. RV without RO (RAO and/or RVO)
Time frame: over a one-year period from 01/012019 to 31/12/2019
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals