A Real-World Evidence Study for the Incidence of Retinal... | NCT06769412

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2025Actual

Primary Completion Date

Aug 15, 2025Actual

Completion Date

Sep 1, 2025Actual

First Submitted Date

Dec 24, 2024

First Submission Date that Met QC Criteria

Jan 9, 2025

First Posted Date

Jan 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2025

Last Update Posted Date

Oct 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will describe and estimate the incidence of RV events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea® 2mg) therapy in US clinical practice. This study will also use clinical record review to confirm cases of RV first identified using International Classification of Diseases, tenth revision, Clinical Modification (ICD-10-CM) codes and to identify RV with occlusion.

Detailed Description

This study is purely descriptive using secondary data from the Verana Health Retinal Outcomes module sourced from the American Academy of Ophthalmology's Intelligent Research in Sight (IRIS®) Registry

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

550,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aflibercept IVT Cohort		Patients ≥ 18 years who initiated aflibercept 2 mg IVT during the study period	Drug: aflibercept 2 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aflibercept 2 mg	Drug	No study-specific investigations for this descriptive observational study	Aflibercept IVT Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Patient-eyes with at least one aflibercept 2 mg injection between January 1, 2017 and June 30, 2023
Patient-eyes with at least one aflibercept 2 mg injection with a specified laterality. The earliest date of aflibercept injection will be the index date for each patient-eye
Patient-eyes with diagnosis (documented through ICD-10-CM diagnosis code) of nAMD, DME, DR without DME, DR with ME status unknown, and/or ME following RVO in the same eye as the aflibercept injection within 14 days prior to the index date (inclusive)

Key Exclusion Criteria:

Patients with aflibercept 2 mg injection within 12 months (365 days) prior to the index date (not inclusive) will be excluded, as defined in the protocol
Patient-eyes with a diagnosis of RV in the same eye as the aflibercept injection or with unspecified laterality within 12 months (365 days) prior to index date (inclusive), as defined in the protocol
Aflibercept treatment episodes (aflibercept injections) with unspecified laterality, ophthalmic procedures or surgeries within 60 days prior to the injection date

NOTE: Other protocol defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample

ID	Term
D031300	Retinal Vasculitis
D003930	Diabetic Retinopathy

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D014657	Vasculitis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D003925	Diabetic Angiopathies
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases