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Neovascular Age-Related Macular DegenerationPhase 3ELARANCT06491914

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)

A Phase 3 study testing Aflibercept 8 mg in people with Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema, run by Regeneron Pharmaceuticals at 54 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aflibercept 8 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,126 participants
Where
54 sitesin 2 countries
Study dates
24 Jul 2024to 7 Jan 2027
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥50 years of age
  • History of choroidal neovascularization (CNV) lesions secondary to nAMD in the eye study, requiring continued anti-VEGF treatment, as determined by the investigator.
  • ≥18 years of age
  • 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
  • Previously treated with ≥3 anti-VEGF IVT injections in the study eye in the 5 months (~150 days) prior to visit 1

Who cannot join

  • Evidence of CNV due to any cause other than nAMD in either eye
  • Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye
  • Active proliferative diabetic retinopathy (DR) in the study eye
  • NOTE: Other protocol defined inclusion / exclusion criteria apply.

Trial locations and contacts

54 sites in 2 countries.

54 sites in 2 countries

United States53 sites

  • Retina Consultants of Hawaii, Inc.

    ‘Aiea, Hawaii, 96701

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • Win Retina - Arcadia

    Arcadia, California, 91006

  • Austin Retina Associates

    Austin, Texas, 78705

  • California Retina Consultants

    Bakersfield, California, 93309

  • Retina Associates of Cleveland - Beachwood

    Beachwood, Ohio, 44122

  • Retina Consultants of Texas

    Beaumont, Texas, 77707

  • Retina Consultants of Texas - Houston

    Bellaire, Texas, 77401

  • Pacific Northwest Retina

    Bellevue, Washington, 98004

  • Mid Atlantic Retina

    Bethlehem, Pennsylvania, 18017

  • Retina Specialists of Beverly Hills

    Beverly Hills, California, 90212

  • Opthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909

  • Texas Retina Associates - Dallas

    Dallas, Texas, 75231

  • Advanced Research, LLC

    Deerfield Beach, Florida, 33064

  • Retina Consultants of Minnesota

    Edina, Minnesota, 55435

  • Southwest Retina Consultants

    El Paso, Texas, 79902

  • Cumberland Valley Retina Consultants-Ophthalmology

    Hagerstown, Maryland, 21740

  • Mid Atlantic Retina Specialists Hagerstown

    Hagerstown, Maryland, 21740

  • Salehi Retina Institute dba Retina Associates of Southern California

    Huntington Beach, California, 92647

  • Florida Retina Institute - Jacksonville

    Jacksonville, Florida, 32216

  • Retina Consultants of Texas

    Katy, Texas, 77494

  • Charleston Neuroscience Institute LLC

    Ladson, South Carolina, 29456

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • University Retina and Macula Associates PC - Lemont

    Lemont, Illinois, 60439

  • South Coast Retina Center

    Long Beach, California, 90807

  • Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute

    Longmont, Colorado, 80503

  • Georgia Retina

    Marietta, Georgia, 30060

  • Tennessee Retina, PC

    Nashville, Tennessee, 37203

  • Illinois Retina Associates

    Oak Park, Illinois, 60304

  • Florida Retina Institute - Orlando

    Orlando, Florida, 32806

  • California Eye Specialists Medical Group, Inc.

    Pasadena, California, 91107

  • Retina Speciality Institute - Pensacola, Florida

    Pensacola, Florida, 32503

  • Eye Associates of Pinellas

    Pinellas Park, Florida, 33782

  • EyeHealth Northwest

    Portland, Oregon, 97225

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Austin Retina Associates

    Round Rock, Texas, 78681

  • Vrmg Inc

    Sacramento, California, 95825

  • Retina Consultants of Texas

    San Antonio, Texas, 78240

  • Retina Consultants of Texas Brown Retina Institute

    San Antonio, Texas, 78251

  • Sewickley Eye Group

    Sewickley, Pennsylvania, 15143

  • Deep Blue Retina Clinical Research PLLC

    Southaven, Mississippi, 38671

  • Retina Vitreous Associates of Florida Saint Petersburg

    St. Petersburg, Florida, 33711

  • Retina Vitreous Associates of Florida

    Tampa, Florida, 33617

  • Retina Consultants Texas

    The Woodlands, Texas, 77384

  • Tulsa Retina Consultants

    Tulsa, Oklahoma, 74114

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27587

  • Retina Group of New England

    Waterford, Connecticut, 06385

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Vitreoretinal Consultants of NY - Westbury

    Westbury, New York, 11590

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

Puerto Rico1 site

  • Emanuelli Research and Development Center

    Arecibo, 00612

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Aflibercept 8 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aflibercept 8 mgDrug

    Also called EYLEA®HD, BAY86-5321

    Administered by intravitreal (IVT) injection

Study groups in NCT06491914
Study groupRoleWhat they receive
Aflibercept 8 mgExperimentalParticipants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications
Receives: Drug: Aflibercept 8 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants With at Least One Treatment-emergent Adverse Event (TEAE)

    Measured: Through week 24

  2. Participants With at Least One Serious TEAE

    Measured: Through week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start24 Jul 2024
  3. Primary completion26 Aug 2025
  4. Study completion7 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06491914
Sponsor's protocol ID
VGFTe-HD-OD-2444
Acronym
ELARA
Status last verified
Aug 2026
First submitted
1 Jul 2024
Last updated
18 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Publications

  • Brown DM, Rao R, Berliner AJ, Patel D, Cheng Y, Bai Z, Wykoff CC. Study Design for ELARA, a Phase 3b Trial of Aflibercept 8 mg in Previously Treated Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema. Ophthalmol Ther. 2026 Oct 9. doi: 10.1007/s40123-026-01499-7. Online ahead of print.

    PubMed 42853354

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