Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD) Who Received Anti-vascular Endothelial Growth Factor (VEGF) Agents (Komodo Health)

NCT05146687 | Completed

• 1 other identifier: CRTH258AUS19
• Study Type: observational
• Target: 369,600
• Locations: 1 country
• Sites: 1

Brief Summary

This was the cross-sectional study to assess the 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.

Conditions

Age-related Macular Degeneration (AMD)

Keywords

AMD,; brolucizumab,; anti-VEGF switchers,; treatment-naive

Outcome Measures

Primary Outcomes (1)

• 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.

  earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019

Secondary Outcomes (9)

• Age

  earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019

• Gender information

  earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019

• Number of patients at various Patient Region

  earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019

• Number of patients with Insurance type

  earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019

• Number of patients with Laterality of wet Age-related macular degeneration (AMD)

  Index date (defined as the date of first injection - 01/01/2019)

Study Arms (4)

Aflibercept

Patients/patient eyes who were treated only with aflibercept in 2019

Other: Aflibercept

Ranibizumab

Patients/patient eyes who were treated only with ranibizumab in 2019

Other: Ranibizumab

Bevacizumab

Patients/patient eyes who were treated only with bevacizumab in 2019

Other: Bevacizumab

≥2 Different Anti- VEFGFs

Patients/patient eyes who were treated with ≥2 different anti-VEGFs in 2019

Interventions

Aflibercept OTHER

intravitreal injection

Also known as: EYLEA®

Aflibercept

Ranibizumab OTHER

intravitreal injection

Also known as: LUCENTIS®

Ranibizumab

Bevacizumab OTHER

intravitreal injection

Also known as: AVASTIN®; off-label use

Bevacizumab

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included patients with wet AMD who received ≥1 anti-VEGF injection (excluding brolucizumab)

You may qualify if:

• ≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in 2019
• ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or National Drug Code (NDC) code for treatment with an anti-VEGF agent (excluding brolucizumab) in 2019
• ≥18 years old in 2019
• ≥2 wet AMD-related office visits in 2019

You may not qualify if:

• \- ≥1 HCPCS code (J code) or NDC code for treatment with brolucizumab in 2019

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

• Results for CRTH258AUS19 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept; Ranibizumab; Bevacizumab; Off-Label Use

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Prescriptions; Drug Therapy; Therapeutics

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 7, 2021
• Study Start: July 15, 2020
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

US (1)