Wet Age Related Macular DegenerationPhase 3wAMDNCT06683742
A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) 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 113 sites in 10 countries.
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
- 113 sitesin 10 countries
- Study dates
- 27 Nov 2024to Oct 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
113 sites in 10 countries.
113 sites in 10 countries
United States78 sites
Panhandle Eye Group, LLP. - Southwest Retina Specialists
Amarillo, Texas, 79106
Win Retina
Arcadia, California, 91006
Texas Retina Associates
Arlington, Texas, 76012
Austin Research Center for Retina
Austin, Texas, 45674
Austin Retina Associates
Austin, Texas, 78705
Austin Clinical Research LLC
Austin, Texas, 78750
Pacific Northwest Retina
Bellevue, Washington, 98004
Wills Eye Physician Mid Atlantic Retina
Bethlehem, Pennsylvania, 18017
Doctor Retina, PC
Beverly Hills, California, 90211
Envision Ocular, LLC
Bloomfield, New Jersey, 07003
Gailey Eye Clinic
Bloomington, Illinois, 60616
Star Vision Research
Burleson, Texas, 76028
AVRUC
Carmel, Indiana, 46032
NC Retina Associates - Cary Research
Cary, North Carolina, 27511
Mid Atlantic Retina
Cherry Hill, New Jersey, 08034
Blue Ocean Clinical Research
Clearwater, Florida, 33761
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909
Connecticut Eye Consultants, P.C.
Danbury, Connecticut, 06810
Rand Eye Institute
Deerfield Beach, Florida, 33064
RSC Research, PLLC
Denver, Colorado, 80210
NJ Retina
Edison, New Jersey, 08820
Retina Vitreous Center, PLLC
Edmond, Oklahoma, 73013
Retina Associates
Elmhurst, Illinois, 60126
The Retina Partners
Encino, California, 91436
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80528
Retina Group of Florida
Fort Lauderdale, Florida, 33308
RCOC Clinical Research Institute Inc.
Fullerton, California, 92835
Associated Retina Consultans
Gilbert, Arizona, 85297
Global Research Management, Inc.
Glendale, California, 91204
Retina Associates of Michigan
Grand Blanc, Michigan, 48439
SightSera Clinical Research LLC
Greenwich, Connecticut, 06830
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740
Graystone Eye - Hickory Office
Hickory, North Carolina, 28602
Berkeley Eye Center
Houston, Texas, 77027
Atlantis Eyecare
Huntington Beach, California, 92647
Retina Consultants of Texas
Katy, Texas, 77494
Colorado Retina Associates
Lakewood, Colorado, 80228
The Eye Institute of West Florida
Largo, Florida, 33770
Retina Associates of Kentucky
Lexington, Kentucky, 40509
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York, 13088
South Coast Retina Center
Long Beach, California, 90807
The Eye Care Institute
Louisville, Kentucky, 40206
Valley Retina Institute P.A.
McAllen, Texas, 78503
Retina Associates New Orleans
Metairie, Louisiana, 70006
Retinal Consultants Medical Group
Modesto, California, 95356
Northern California Retina Vitreous Associates Medical Group INC.
Mountain View, California, 94040
Tennessee Retina
Nashville, Tennessee, 37203
NYC Retina
New York, New York, 45604
Illinois Retina Associates, S.C.
Oak Park, Illinois, 60304
Kaiser Permanente
Oakland, California, 94611
California Retina Consultants Oxnard Office
Oxnard, California, 93036
Retina Care Specialists
Palm Beach Gardens, Florida, 45674
Associated Retina Consultants - Phoenix
Phoenix, Arizona, 85020
Phoenix Retina Clinical Trials, LLC
Phoenix, Arizona, 85050
3RP/ Windy City Retina
Plainfield, Illinois, 60586
Texas Retina Associates
Plano, Texas, 75075
Fort Lauderdale Eye Institute
Plantation, Florida, 33324
Black Hills Regional Eye Institute
Rapid City, South Dakota, 45526
California Eye Specialists Medical Group, Inc.
Redlands, California, 92373
Retina Consultants of Southern California
Redlands, California, 92374
Retina Associates of Western NY, PC
Rochester, New York, 14620
VRMG Inc
Sacramento, California, 95825
TX RCTX Retina Consultants of Texas
San Antonio, Texas, 78154
Retina Associates of South Texas
San Antonio, Texas, 78240
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255
MedEye Associates
South Miami, Florida, 33143
Cascade Medical Research lnstitute, LLC
Springfield, Oregon, 97477
Retina Vitreous Associates of Florida - Saint Petersburg
St. Petersburg, Florida, 33711
East Florida Eye Institute
Stuart, Florida, 34994
Retina Specialists of Tampa
Tampa, Florida, 33618
Tyler Retina Consultants
Tyler, Texas, 75703
North Carolina Retina Associates
Wake Forest, North Carolina, 27587
Bay Area Retina Associates
Walnut Creek, California, 94598
Virginia Retina Center
Warrenton, Virginia, 20186
Haik Humble Eye Center
West Monroe, Louisiana, 71291
VRCNY/Long Island Vitreoretinal Consultants
Westbury, New York, 11590
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, 01605
Israel7 sites
Shamir Medical Center Ophthalmology Out Patient Clinic
Be’er Ya‘aqov
Bnai Zion Medical Center
Haifa
Carmel Medical Center
Haifa
Meir Medical Center Ophthalmology Department
Kfar Saba
Rabin Medical Center
Petah Tikva
Kaplan Medical Center
Rehovot
The Tel-Aviv Sourasky Medical Centre
Tel Aviv
Poland7 sites
OFTALMIKA Sp. z o.o
Bydgoszcz
Szpital sw. Rozy- obsolete; New Name: Szpital Św. Róży sp. z o.o.
Krakow
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin
Centrum Diagnostyki i Mikrochirurgii Oka -LENS Sp. z o. o
Olsztyn
Centrum Medyczne UNO-MED
Tarnów
Piasta 47 Centrum Medyczne
Warsaw
Warszawski Szpital Okulistyczny
Warsaw
India6 sites
Rising Retina Clinic
Ahmedabad
Netralayam VIP
Kolkata
Shanti Saroj Netralay
Miraj
K. B. Haji Bachooali Charitable Ophthalmic & E.N.T. Hospital
Mumbai
Shroff Eye Hospital
Mumbai
Netrodaya - The Eye City
Varanasi
Brazil5 sites
Retina Prime at Jardim Europa Medical Center
Aracaju
Centro Brasileiro de Pesquisa Clinica - Blumenau
Blumenau
Clínica Oftalmológica São Lucas - Retina Clinic
São Paulo
Hospital de Olhos Oeste Paulista
São Paulo
Hospital Oftalmológico de Sorocaba (Centro de Estudos)
Sorocaba
Hungary4 sites
Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest
Budapest Retina Associates
Budapest
Debreceni Egyetem KK Szemklinika
Debrecen
Ganglion Medical Center
Pécs
Czechia3 sites
VISUS, spol s.r.o.
Náchod
Axon Clinical, s.r.o.
Prague
Fakultni nemocnice Kralovske Vinohrady
Prague
Slovakia1 site
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
Banská Bystrica
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.
- Conditions
- Wet Age Related Macular Degeneration, wAMD
- 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 group | Role | What they receive |
|---|---|---|
| EYP-1901 2686 µg | Experimental | EYP-1901 Receives: Drug: EYP-1901 |
| Aflibercept | Active comparator | Not described Receives: Drug: Aflibercept (2.0 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in best corrected visual acuity (BCVA)
Measured: Weeks 52 and 56
Secondary outcomes (2)
Rate of injection burden
Measured: Week 56
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.
- First posted12 Nov 2024
- Study start27 Nov 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683742
- Sponsor's protocol ID
- EYP-1901-302
- Acronym
- wAMD
- Status last verified
- Sep 2026
- First submitted
- 8 Nov 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06683742
- Acronym / sponsor ID
- wAMD / EYP-1901-302
- Conditions
- Wet Age Related Macular Degeneration, wAMD
- Keywords
- Wet Age-related Macular Degeneration, Tyrosine Kinase Inhibitor, EYP-1901, EyePoint
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EYP-1901 2686 µg | Experimental | Drug: EYP-1901EYP-1901 |
| Aflibercept | Active comparator | Drug: Aflibercept (2.0 mg) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Subfoveal fibrosis, atrophy, or scarring in the center subfield.
- BCVA using ETDRS charts <20 letters (20/400 Snellen equivalent) in the fellow eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EYP-1901Intravitreal Injection | Drug | EYP-1901 2686 µg |
| Aflibercept (2.0 mg)Intravitreal Injection | Drug | Aflibercept |
Primary outcome
Average change in best corrected visual acuity (BCVA)
Time frame: Weeks 52 and 56
2 secondary outcomes
Rate of injection burden
Time frame: Week 56
Average change in best corrected visual acuity (BCVA)
Time frame: Week 96
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
113 sites in 10 countries: see every site and its status.
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 113 sites in 10 countries.
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 113 sites in United States, Israel, Poland, India, Brazil and 5 more countries. 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?
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.