An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting

Real-World Patient Characteristics, Treatment Patterns, and Outcomes Among Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) Treated With Aflibercept 8 mg in the United States

NCT06398080•Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this research study is to observe the patient's clinical care and how EYLEA® HD is used as a treatment in real-world settings. Patients are asked to join the study because they have either neovascular age-related macular degeneration (nAMD/wet age-related macular degeneration \[AMD\]) or diabetic macular edema (DME). Patients cannot have used EYLEA® HD in the past and the doctor must be planning to treat nAMD or DME with a new prescription of EYLEA® HD (aflibercept 8 mg).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Any patient aged at least 50 years at the time of enrollment
•2. Diagnosis of nAMD (per physician)
•3. Previously treated patient cohort, patients that had treatment with any ocular intervention for nAMD in the study eye at any time before starting aflibercept 8 mg, as defined in the protocol
•4. For treatment-naïve patient cohort, patients never receiving previous treatment in the study eye for nAMD, as defined in the protocol
•5. Initiating treatment with aflibercept 8 mg for nAMD
•1. Any patient aged at least 18 years at the time of enrollment
•2. Macular edema associated with DME (per physician)
•3. Diagnosis of diabetes mellitus type 1 or type 2
•4. For previously treated patient cohort, treatment with another intravitreal (IVT) anti-VEGF agent(s) or IVT steroids, or surgery/laser for DME in the study eye at any time before starting aflibercept 8 mg, as described in the protocol
•5. For treatment-naïve patient cohort, patients never previously treated with IVT agents or surgery/laser in the study eye for DME
+1 more criteria

Exclusion Criteria

•1. Macular edema/hemorrhage/choroidal neovascularization due to any other cause besides nAMD
•2. Any systemic or ocular condition that would prevent any improvement of VA in the study eye (eg, permanent visual impairment or blindness from any cause)
•3. Any patients that have been treated with photodynamic therapy
•4. Treatment with aflibercept 8 mg prior to baseline
•1. Macular edema due to any other cause besides DME
•2. Any systemic or ocular condition that would prevent any improvement of visual acuity in the study eye (eg, permanent visual impairment or blindness from any cause)
•3. Treatment with aflibercept 8 mg prior to baseline

Key Dates

Start Date

December 12, 2024

Primary Completion Date

January 3, 2028

Completion Date

January 3, 2029

Last Updated

November 25, 2024

Conditions

Neovascular Age-related Macular Degeneration (nAMD)Wet Age-related Macular Degeneration (AMD)Diabetic Macular Edema (DME)Visual Impairment

Interventions

aflibercept 8 mg

DRUG

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449936

Diabetic Macular EdemaDME+1 more

View study

RECRUITINGPHASE3

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449923

Diabetic Macular EdemaDME+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting

Inclusion Criteria

Exclusion Criteria

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

A Study of Avoralstat In Participants With Diabetic Macular Edema

The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema

RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema