Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Anti-vascular endothelial growth factorAfliberceptNeovascular age-related macular degeneration (nAMD)Diabetic macular edema (DME)Diabetic retinopathy (DR) without macular edema (ME)Diabetic retinopathy (DR) with macular edema (ME)

Outcome Measures

Primary Outcomes (4)

Incidence of RV events
During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Incidence of occlusive RV events confirmed through clinical chart abstraction
During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Incidence of non-occlusive RV events confirmed through clinical chart abstraction
During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years
Incidence of unconfirmed RV events
During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 6.5 years

Study Arms (1)

Aflibercept IVT Cohort

Patients ≥ 18 years who initiated aflibercept 2 mg IVT during the study period

Drug: aflibercept 2 mg

Interventions

aflibercept 2 mgDrug

No study-specific investigations for this descriptive observational study

Also known as: Eylea®

Aflibercept IVT Cohort

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The study population will represent patients and patient-eyes who initiate aflibercept 2 mg injections to treat neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR) without DME, DR with macular edema (ME) status unknown, or ME following retinal vein occlusion (RVO).

You may qualify if:

Patient-eyes with at least one aflibercept 2 mg injection between January 1, 2017 and June 30, 2023

Sponsors & Collaborators

Regeneron Pharmaceuticals
Industrylead

Study Sites (1)

Regeneron Research Site

Tarrytown, New York, 10591, United States

MeSH Terms

Conditions

Retinal VasculitisDiabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesDiabetic AngiopathiesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Enrollment

550,000 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 10, 2025

Study Start

July 1, 2025

Actual (reported)

A Real-World Evidence Study for the Incidence of Retinal Vasculitis (RV) Among Adult Patients Receiving Aflibercept 2 mg in the United States (US)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

Aflibercept IVT Cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

Aflibercept IVT Cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations