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Wet Age Related Macular DegenerationPhase 3wAMDNCT06668064

A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 56

A Phase 3 study testing EYP-1901 and Aflibercept (2.0 mg) in people with Wet Age Related Macular Degeneration and wAMD, run by EyePoint Pharmaceuticals, Inc. at 76 sites in United States.

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 is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Wet Age Related Macular Degeneration, wAMD
What is being tested?
EYP-1901 and Aflibercept (2.0 mg)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
76 sitesUnited States
Study dates
22 Oct 2024to Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Previously treated or treatment naïve patients with a documented diagnosis of wAMD in the study eye, with onset of disease that began at any time prior to the Screening Visit.
  • Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score between 78 to 35 letters (approximately 20/32 to 20/200 Snellen equivalent) in the study eye at the Screening Visit and on Baseline (Day 1).
  • For previously-treated subjects, must have been treated with at least 2 anti-VEGF IVT injections (i.e., aflibercept 2 mg, aflibercept 8 mg, bevacizumab, ranibizumab, or faricimab) in the previous 6 months for wAMD per standard of care in the study eye prior to the Screening Visit.

Who cannot join

  • Subfoveal fibrosis, atrophy, or scarring in the center subfield.
  • BCVA using ETDRS charts <20 letters (20/400 Snellen equivalent) in the fellow eye.

Trial locations and contacts

76 sites in 1 country.

76 sites in 1 country

United States76 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Retina Research Institute of Texas Integrated Clinical Research

    Abilene, Texas, 79606

  • Vision Research Center at Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • Western Carolina Retinal Associates, PA

    Asheville, North Carolina, 28803

  • California Retina Consultants

    Bakersfield, California, 93309

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Retina and Vitreous of Texas

    Bellaire, Texas, 77401

  • Retina Consultants of Texas (Retina Consultants of Houston) - Woodlands

    Bellaire, Texas, 77401

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Ophthalmic Consultants of Boston OCB - Boston

    Boston, Massachusetts, 02114

  • Midwest Eye Institute

    Carmel, Indiana, 46290

  • Retina Consultants

    Charleston, South Carolina, 29414

  • Retina Groups of Washington

    Chevy Chase, Maryland, 20815

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Connecticut Eye Consultants, P.C.

    Danbury, Connecticut, 06810

  • Advanced Research, LLC

    Deerfield Beach, Florida, 33064

  • RSC Research, PLLC

    Denver, Colorado, 80210

  • Retina Associates

    Elmhurst, Illinois, 60126

  • Erie Retina Research

    Erie, Pennsylvania, 16507

  • Verum Research LLC

    Eugene, Oregon, 97401

  • The Retina Group of Washington

    Fairfax, Virginia, 22031

  • Palmetto Retina Center

    Florence, South Carolina, 29169

  • Eye Center of Northern Colorado, PC

    Fort Collins, Colorado, 80528

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Macula and Retina Institute

    Glendale, California, 91203

  • Retina Associates of Michigan

    Grand Blanc, Michigan, 48439

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49546

  • Retina Consultants of Carolina P.A

    Greenville, South Carolina, 29605

  • SightSera Clinical Research LLC

    Greenwich, Connecticut, 06830

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Eye Care Specialists - Kingston Location

    Kingston, Pennsylvania, 18704

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • University Retina and Macula Associates

    Lemont, Illinois, 60439

  • Retina Associates LLC

    Lenexa, Kansas, 66215

  • Retina Vitreous Surgeons of CNY, PC

    Liverpool, New York, 13088

  • Advanced Vision Institute

    Longmont, Colorado, 80503

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • University of Wisconsin School of Medicine and Public Health (UWSMPH)

    Madison, Wisconsin, 53705

  • Gerogia Retina

    Marietta, Georgia, 30060

  • Florida Retina Institute

    Orlando, Florida, 32806

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85053

  • Eye Associates of Pinellas

    Pinellas Park, Florida, 33782

  • Texas Retina Associates

    Plano, Texas, 75075

  • Maine Eye Center

    Portland, Maine, 04101

  • Retina Consultants San Diego

    Poway, California, 92064

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Associates of Western NY, PC

    Rochester, New York, 14620

  • Retinal Consultants Medical Group

    Sacramento, California, 95841

  • Retina Associates of Utah

    Salt Lake City, Utah, 84107

  • San Antonio Eye Center

    San Antonio, Texas, 78215

  • Retinal Consultants of Texas

    San Antonio, Texas, 78240

  • Retina Consultants PLLC

    Slingerlands, New York, 12159

  • MedEye Associates

    South Miami, Florida, 33143

  • Deep Blue Retina Clinical Research PLLC

    Southaven, Mississippi, 38671

  • Retina Partners of Northwest Arkansas

    Springdale, Arkansas, 72764

  • New England Retina Consultants

    Springfield, Massachusetts, 01107

  • The Retina Institute

    St Louis, Missouri, 63128

  • Retina Specialists of Tampa

    Tampa, Florida, 33544

  • Retina Vitreous Associates of Florida

    Tampa, Florida, 33617

  • NJ Retina

    Teaneck, New Jersey, 07666

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384

  • NJ Retina

    Toms River, New Jersey, 08755

  • Retina Specialists

    Towson, Maryland, 21204

  • Tulsa Retina Consultant

    Tulsa, Oklahoma, 74114

  • Tyler Retina Consultants

    Tyler, Texas, 75703

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Retina Group of New England, PC

    Waterford, Connecticut, 06385

  • Salt Lake Retina

    West Jordan, Utah, 84088

  • American Institute of Research

    Whittier, California, 95008

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Cape Fear Retinal Associates, PC

    Wilmington, North Carolina, 28401

  • Retina Associates, P.C.

    Winchester, Virginia, 22601

  • Piedmont Retina Specialists, P.A. - Winston-Salem Office

    Winston-Salem, North Carolina, 27103

  • Center for Retina & Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: A 2-year Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.

Being tested
EYP-1901, Aflibercept (2.0 mg)
Keywords
Wet Age-related Macular Degeneration, Tyrosine Kinase Inhibitor, EYP-1901, EyePoint

What participants receive

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

  • EYP-1901Drug

    Intravitreal Injection

  • Aflibercept (2.0 mg)Drug

    Intravitreal Injection

Study groups in NCT06668064
Study groupRoleWhat they receive
EYP-1901 2686 µgExperimentalEYP-1901
Receives: Drug: EYP-1901
AfliberceptActive comparatorNot described
Receives: Drug: Aflibercept (2.0 mg)

What is being measured

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

  1. Average change in best corrected visual acuity (BCVA)

    Measured: Weeks 52 and 56

Secondary outcomes (2)

  1. Rate of injection burden

    Measured: Week 56

  2. Average change in best corrected visual acuity (BCVA)

    Measured: Week 96

Timeline

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

  1. First posted31 Oct 2024
  2. Study start22 Oct 2024
  3. Primary completion13 Jul 2026
  4. Study completionAug 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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06668064
Sponsor's protocol ID
EYP-1901-301
Acronym
wAMD
Status last verified
Sep 2026
First submitted
30 Oct 2024
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EYP-1901 and Aflibercept (2.0 mg) in people with Wet Age Related Macular Degeneration and wAMD, run by EyePoint Pharmaceuticals, Inc. at 76 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average change in best corrected visual acuity (BCVA) (time frame: Weeks 52 and 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06668064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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