A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME) (ELARA)

October 13, 2025 updated by: Regeneron Pharmaceuticals

A Phase 3b Single-Arm Study of Aflibercept 8 mg in Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications.

The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1118

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Emanuelli Research and Development Center
  • United States
    • California
      • Arcadia, California, United States, 91006
        • Win Retina - Arcadia
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Beverly Hills, California, United States, 90212
        • Retina Specialists of Beverly Hills
      • Huntington Beach, California, United States, 92647
        • Salehi Retina Institute dba Retina Associates of Southern California
      • Long Beach, California, United States, 90807
        • South Coast Retina Center
      • Pasadena, California, United States, 91107
        • California Eye Specialists Medical Group, Inc.
      • Redlands, California, United States, 92374
        • Retina Consultants of Southern California
      • Sacramento, California, United States, 95825
        • Vrmg Inc
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado
      • Longmont, Colorado, United States, 80503
        • Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute
    • Connecticut
      • Waterford, Connecticut, United States, 06385
        • Retina Group of New England
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Advanced Research, LLC
      • Jacksonville, Florida, United States, 32216
        • Florida Retina Institute - Jacksonville
      • Lakeland, Florida, United States, 33805
        • Florida Retina Consultants
      • Orlando, Florida, United States, 32806
        • Florida Retina Institute - Orlando
      • Pensacola, Florida, United States, 32503
        • Retina Speciality Institute - Pensacola, Florida
      • Pinellas Park, Florida, United States, 33782
        • Eye Associates of Pinellas
      • St. Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida Saint Petersburg
      • Tampa, Florida, United States, 33617
        • Retina Vitreous Associates of Florida
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Georgia Retina
    • Hawaii
      • ‘Aiea, Hawaii, United States, 96701
        • Retina Consultants of Hawaii, Inc.
    • Illinois
      • Lemont, Illinois, United States, 60439
        • University Retina and Macula Associates PC - Lemont
      • Oak Park, Illinois, United States, 60304
        • Illinois Retina Associates
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants-Ophthalmology
      • Hagerstown, Maryland, United States, 21740
        • Mid Atlantic Retina Specialists Hagerstown
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Opthalmic Consultants of Boston
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Retina Consultants of Minnesota
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Deep Blue Retina Clinical Research PLLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Vision Research Center Eye Associates of New Mexico
    • New York
      • Westbury, New York, United States, 11590
        • Vitreoretinal Consultants of NY - Westbury
    • North Carolina
      • Wake Forest, North Carolina, United States, 27587
        • North Carolina Retina Associates
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Retina Associates of Cleveland - Beachwood
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Tulsa Retina Consultants
    • Oregon
      • Portland, Oregon, United States, 97225
        • EyeHealth Northwest
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Mid Atlantic Retina
      • Sewickley, Pennsylvania, United States, 15143
        • Sewickley Eye Group
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Institute LLC
      • West Columbia, South Carolina, United States, 29169
        • Palmetto Retina Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina, PC
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Beaumont, Texas, United States, 77707
        • Retina Consultants of Texas
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas - Houston
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates - Dallas
      • El Paso, Texas, United States, 79902
        • Southwest Retina Consultants
      • Katy, Texas, United States, 77494
        • Retina Consultants of Texas
      • Round Rock, Texas, United States, 78681
        • Austin Retina Associates
      • San Antonio, Texas, United States, 78240
        • Retina Consultants of Texas
      • San Antonio, Texas, United States, 78251
        • Retina Consultants of Texas Brown Retina Institute
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants Texas
    • Washington
      • Bellevue, Washington, United States, 98004
        • Pacific Northwest Retina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria for Participants with nAMD:

  1. ≥50 years of age

  2. History of choroidal neovascularization (CNV) lesions secondary to nAMD in the eye study, requiring continued anti-VEGF treatment, as determined by the investigator.

    Key Inclusion Criteria for Participants with DME:

  3. ≥18 years of age

  4. History of DME with central involvement (in the central subfield on Spectral domain optical coherence tomography [SD-OCT]) in the study eye, requiring continued anti-VEGF treatment, as determined by the investigator

    Key Inclusion for All Participants:

  5. Previously treated with ≥3 anti-VEGF IVT injections in the study eye in the 5 months (~150 days) prior to visit 1

Key Exclusion Criteria for Participants with nAMD:

  1. Evidence of CNV due to any cause other than nAMD in either eye

    Key Exclusion Criteria for Participants with DME:

  2. Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye
  3. Active proliferative diabetic retinopathy (DR) in the study eye

NOTE: Other protocol defined inclusion / exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aflibercept 8 mg
Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications
Drug: Aflibercept 8 mg
Administered by intravitreal (IVT) injection
Other Names:
  • BAY86-5321
  • EYLEA®HD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of treatment-emergent adverse events (TEAEs)
Time Frame: Through week 24
Through week 24
Occurrence of serious TEAEs
Time Frame: Through week 24
Through week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2024

Primary Completion (Actual)

August 26, 2025

Study Completion (Estimated)

January 7, 2027

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

October 13, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFTe-HD-OD-2444

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued developed of the product for all indications on or after April 2020 and has no plans for future development
  • made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy.

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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