Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)
Completed
Conditions studied: Age-related Macular Degeneration (AMD)
In brief
This study was a retrospective cohort study of patients to assess the early insights into real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to describe their patient characteristics and clinical outcomes. The study was conducted using the IRIS Registry.
Key facts
- Study ID
- NCT05082415
- Run by
- Novartis Pharmaceuticals
- People needed
- 9456
- Starts
- 2020-06-03
- Expected to finish
- 2020-12-15
- Last updated by the study team
- 2021-10-27
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or EMR note for treatment with brolucizumab during the index period (date of earliest code or EMR note = index date)
- ≥18 years old on the index date
- ≥1 Current Procedural Terminology (CPT) code for intravitreal administration 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
- o Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US.
- ≥1 follow-up visit after the index date
- ≥1 VA assessment on the index date or within 90 days prior to the index date
You may not qualify if…
- Use of brolucizumab prior to 10/8/2019 (e.g. clinical trials)
- Unknown laterality of the index eye on the index date
Where it is running
- Novartis Pharmaceuticals — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
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