Wet Age-related Macular DegenerationPhase 2DAVIO2NCT05381948
Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)
A Phase 2 study testing EYP-1901 and Aflibercept 2mg/0.05mL Inj,Oph in people with Wet Age-related Macular Degeneration, run by EyePoint Pharmaceuticals, Inc. at 67 sites in United States.
Trial summary
This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at 2 dose levels: 2060 microgram (mcg) and 3090 mcg 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
- What is being tested?
- EYP-1901 and Aflibercept 2mg/0.05mL Inj,Oph
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 67 sitesUnited States
- Study dates
- 30 Jun 2022to 24 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Documented diagnosis of wAMD in the study eye, with disease onset any time prior to the Screening Visit.
- Documented anatomical response (that is, reduction in fluid on [spectral-domain - optical coherence tomography (SD-OCT)] to previous intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections in the study eye prior to the Screening Visit.
- Previously treated with at least 2 anti-VEGF intravitreal injections (that is, bevacizumab, ranibizumab, aflibercept or faricimab) for wAMD per standard of care in the study eye within 6 months prior to the Screening Visit.
- Received previous anti-VEGF therapy 2 to 5 weeks (14 to 35 days) in the study eye prior to Screening Visit, but no more than 42 days prior to randomization to study treatment on Day 1.
- Best corrected visual acuity (BCVA) early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 35 letters (20/200 Snellen equivalent) to 85 letters (20/20 Snellen equivalent) in the study eye at the Screening Visit and on Day 1.
- Able to understand, and willingness to sign, the informed consent and to provide access to personal health information via Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Willingness and ability to comply with all scheduled visits, restrictions, and assessments.
- For women of childbearing potential, or men with female partners of childbearing potential, agreement to the use of an appropriate form of contraception at the Screening Visit and for the duration of the study.
Who cannot join
- History of pars plana vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye.
- Prior treatment with Visudyne® (verteporfin), external beam radiation therapy, or transpupillary thermotherapy in the study eye.
- Previous treatment with intravitreal corticosteroid injection or device implantation in the study eye.
- Previous focal laser photocoagulation used for AMD treatment in the study eye.
- Total choroidal neovascularization (CNV) lesion size >12 disc areas [30.5 millimeter square (mm^2)] as assessed by fluorescein angiography (FA) in the study eye at the Screening Visit.
- Central subfield thickness (CST) >350 micrometer (mcm) in the study eye at the Screening Visit or Day 1.
Show all 50Show fewer
- Intraretinal cystic fluid >25 mcm in diameter involving the central subfield and/or disruption of normal morphology (loss of foveal depression, disruption of external limiting membrane) secondary to cystic intraretinal fluid within the central subfield, in the study eye at the Screening Visit. Diffuse (non-cystic) intraretinal fluid would not be excluded.
- Subretinal hemorrhage in the subfoveal/juxtafoveal location and hemorrhage greater than 1 disc are (1.8 mm^2) if located less than 200 mcm from the foveal center in the study eye at either the Screening Visit or Day 1.
- Subfoveal fibrosis, atrophy, or scarring in the center subfield in the study eye at the Screening Visit.
- Fibrosis >50% of the total lesion, in the study eye at the Screening Visit.
- Retinal pigment epithelium detachment (RPED) thickness >400 mcm at any point within 3 mm of the foveal center in the study eye at either the Screening Visit or Day 1.
- Retinal pigment epithelial tear in the study eye at the Screening Visit or Day 1.
- Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma) that, in the opinion of the investigator, would have either required surgical intervention during the study to prevent or treat visual loss that might result from that condition or affected interpretation of the study results.
- Historical or active intraocular inflammation (grade trace or above) in the study eye, other than expected findings from routine cataract surgery.
- History of vitreous hemorrhage in the study eye within 12 weeks prior to the Screening Visit.
- History of rhegmatogenous retinal detachment or treatment for retinal detachment or macular hole (stage 3 or 4) in the study eye.
- Aphakia or pseudophakia with the absence of the posterior capsule in the study eye (YAG capsulotomy is permitted).
- Spherical equivalent of the refractive error in the study eye demonstrating >8 diopters of myopia.
- For subjects who have undergone prior refractive or cataract surgery in the study eye, preoperative refractive error in the study eye exceeding 8 diopters of myopia.
- Intraocular surgery (including cataract surgery) in the study eye within 12 weeks prior to the Screening Visit.
- Uncontrolled ocular hypertension or glaucoma in the study eye (defined as intraocular pressure (IOP) >25 mm of mercury (mmHg) or a cup to disc ratio >=0.8, despite treatment with 2 or more classes of antiglaucoma medication) and any such condition which the Investigator feels may require a glaucoma-filtering surgery while in the study.
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye.
- History of corneal transplant in the study eye.
- BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.
- Worsening of BCVA ≥10 ETDRS letters in the study eye from the Screening Visit to Day 1.
- Presence of CNV in either eye due to other causes aside from wAMD at the Screening Visit.
- Treatment with Visudyne® in the fellow eye <7 days prior to the Screening Visit.
- Prior participation in a clinical trial involving investigational anti-angiogenic drugs administered in either eye or systemically within 8 weeks prior to the Screening Visit.
- Prior participation in a clinical trial involving investigational ocular gene therapy trial for either eye.
- History of idiopathic or autoimmune-associated uveitis in either eye.
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- Presence of any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study.
- Uncontrolled blood pressure (defined as systolic >180 mmHg and/or diastolic >100 mmHg), based on the average of three readings taken with the subject in a resting state.
- Myocardial infarction within 6 months prior to screening or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled atrial fibrillation, uncontrolled angina, cardiomyopathy, ventricular arrhythmias or other cardiac conditions which, in the judgment of the investigator, could make the subject inappropriate for entry into this study.
- Serious non-healing wound, ulcer, or bone fracture.
- Glycated hemoglobin (HbA1c) greater than 7% at the Screening Visit.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of EYP-1901.
- Current treatment for any active systemic infection.
- Previous use of any systemic anti-VEGF agents or intraocular brolucizumab in the study eye.
- Use of oral corticosteroids (prednisone >10 mg/day or equivalent) within 30 days prior to the Screening Visit.
- History or presence of bleeding disorders, including platelet disorders, hemorrhage, acquired or hereditary coagulation disorders (including deep vein thrombosis and pulmonary embolisms), acquired or hereditary vascular disorders, stroke, or transient ischemic attack.
- Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study entry.
- History of allergy to fluorescein, not amenable to treatment.
- Inability to obtain fundus photographs, FA, fundus autofluorescence, or SD-OCT images of sufficient quality to be analyzed and graded by the Central Reading Center.
- Historical or active diagnosis of any medical or psychological condition that could interfere with the ability of the subject to give informed consent, or to comply with study or follow-up procedures.
- Previous participation in any ocular or non-ocular (systemic) disease studies of investigational drugs within 30 days prior to the Screening Visit (excluding vitamins and minerals).
- Use of anti-mitotic or anti-metabolite therapy within 30 days or 5 elimination half-lives of the Screening Visit, whichever is longer.
- Intolerance, contraindication, or hypersensitivity to topical anesthetics, dyes, povidone iodine, mydriatic medications, or any of the ingredients of the EYP-1901 insert.
- Requirement for continuous use of any protocol-prohibited medications or treatments.
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception during the study as outlined in this protocol.
Trial locations and contacts
67 sites in 1 country.
67 sites in 1 country
United States67 sites
EyePoint Investigative Site
‘Aiea, Hawaii, 96701
EyePoint Investigative Site
Abilene, Texas, 79606
EyePoint Investigative Site
Asheville, North Carolina, 28803
EyePoint Investigative Sites
Austin, Texas, 78750
EyePoint Investigative Site
Baltimore, Maryland, 21209
EyePoint Investigative Site
Beverly Hills, California, 90211
EyePoint Investigative Site
Boston, Massachusetts, 02114
EyePoint Investigative Site
Campbell, California, 95008
EyePoint Investigative Site
Carmel, Indiana, 46290
EyePoint Investigative Site
Charleston, South Carolina, 29414
EyePoint Investigative Site
Chicago, Illinois, 60616
EyePoint Investigative Site
Clearwater, Florida, 33761
EyePoint Investigative Site
Coral Springs, Florida, 33067
EyePoint Investigative Site
Dallas, Texas, 75231
EyePoint Investigative Site
Encino, California, 91436
EyePoint Investigative Site
Eugene, Oregon, 97401
EyePoint Investigative Site
Fairfax, Virginia, 22031
EyePoint Investigative Site
Fullerton, California, 92835
EyePoint Investigative Site
Germantown, Tennessee, 38138
EyePoint Investigative Site
Glendale, California, 91203
EyePoint Investigative Site
Grand Rapids, Michigan, 49446
EyePoint Investigative Site
Great Neck, New York, 11021
EyePoint Investigative Site
Hagerstown, Maryland, 21740
EyePoint Investigative Site
Hauppauge, New York, 11788
EyePoint Investigative Sites
Houston, Texas, 77025
EyePoint Investigative Site
Huntington Beach, California, 92647
EyePoint Investigative Site
Irvine, California, 92697
EyePoint Investigative Site
Lakeland, Florida, 33805
EyePoint Investigative Site
Lakewood, Colorado, 80228
EyePoint Investigative Site
Lemont, Illinois, 60439
EyePoint Investigative Site
Liverpool, New York, 13088
EyePoint Investigative Site
Lynchburg, Virginia, 24502
EyePoint Investigative Site
Marietta, Georgia, 30060
EyePoint Investigative Site
McAllen, Texas, 78503
EyePoint Investigative Site
Melbourne, Florida, 32901
EyePoint Investigative Site
Miami, Florida, 33143
EyePoint Investigative Site
Nashville, Tennessee, 37203
EyePoint Investigative Site
Owings Mills, Maryland, 21117
EyePoint Investigative Site
Pasadena, California, 91107
EyePoint Investigative Site
Pensacola, Florida, 32503
EyePoint Investigative Site
Phoenix, Arizona, 85053
EyePoint Investigative Site
Plano, Texas, 75075
EyePoint Investigative Site
Portland, Oregon, 97239
EyePoint Investigative Site
Poway, California, 92064
EyePoint Investigative Site
Redlands, California, 92373
EyePoint Investigative Site
Reno, Nevada, 89502
EyePoint Investigative Site
Sacramento, California, 95825
EyePoint Investigative Site
Saint Louis, Michigan, 55416
EyePoint Investigative Site
Salt Lake City, Utah, 84107
EyePoint Investigative Site
San Antonio, Texas, 78240
EyePoint Investigative Site
Sarasota, Florida, 34239
EyePoint Investigative Site
Shirley, New York, 11967
EyePoint Investigative Site
Silverdale, Washington, 98383
EyePoint Investigative Site
Springdale, Arkansas, 72762
EyePoint Investigative Site
Springfield, Massachusetts, 01107
EyePoint Investigative Site
Springfield, Oregon, 97488
EyePoint Investigative Site
St Louis, Missouri, 63128
EyePoint Investigative Site
St. Petersburg, Florida, 33711
EyePoint Investigative Site
Tampa, Florida, 33609
EyePoint Investigative Site
Teaneck, New Jersey, 07666
EyePoint Investigative Site
The Woodlands, Texas, 77384
EyePoint Investigative Site
Wake Forest, North Carolina, 27587
EyePoint Investigative Site
Walnut Creek, California, 94598
EyePoint Investigative Site
Warrenton, Virginia, 20186
EyePoint Investigative Site
West Columbia, South Carolina, 29169
EyePoint Investigative Site
West Des Moines, Iowa, 50266
EyePoint Investigative Site
Winter Haven, Florida, 33880
About this study
Official title: A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD
This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at 2 dose levels: 2060 microgram (mcg) and 3090 mcg against aflibercept.
Read the detailed description
This study is evaluating the 2 doses of EYP-1901 against aflibercept in a randomized study.
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- EYP-1901, Aflibercept 2mg/0.05mL Inj,Oph
- Keywords
- wAMD, 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 2mg/0.05mL Inj,OphDrug
Also called Eylea
Intravitreal Injection
| Study group | Role | What they receive |
|---|---|---|
| EYP-1901 2060 mcg | Experimental | EYP-1901 2060 mcg, single dose Receives: Drug: EYP-1901 |
| EYP-1901 3090 mcg | Experimental | EYP-1901 3090 mcg, single dose Receives: Drug: EYP-1901 |
| Aflibercept | Active comparator | Aflibercept 2 milligram (mg) [0.05 milliliter (mL)] every 8 weeks Receives: Drug: Aflibercept 2mg/0.05mL Inj,Oph |
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) From Baseline Averaged Over Weeks 28 and 32
The BCVA was measured according to the standard procedure originally developed for Early Treatment Diabetic Retinopathy Study (ETDRS). The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Measured: Baseline (Day 1) and Weeks 28 and 32
Secondary outcomes (13)
Change From Baseline in Best Corrected Visual Acuity up to Week 56
The BCVA was measured according to the standard procedure originally developed for ETDRS. The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Measured: Baseline (Day 1) and Weeks 32 and 56
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
The BCVA was measured according to the standard procedure originally developed for ETDRS. The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Measured: Baseline (Day 1) and Weeks 32 and 56
Percentage of Subjects Not Receiving Supplemental Injection of Aflibercept up to Week 56
Supplemental therapy was any unscheduled injection of aflibercept, whether or not a subject had met rescue criteria. For the aflibercept arm, any aflibercept injection following Week 8 which did not occur at Weeks 16, 24, 32, 40, 48, or 56, was supplemental therapy. For either of the EYP-1901 arms, any aflibercept injection following the Week 8 visit was supplemental therapy.
Measured: Weeks 32 and 56
Median Time to First Supplemental Aflibercept Injection in the Study Eye Following the EYP-1901 Dose at Week 8
Time to first supplemental aflibercept injection following Week 8 study treatment was defined as the date of the first supplemental aflibercept injection minus the date of the Week 8 study treatment administration, divided by 7 days per week. Subjects who did not receive any supplemental aflibercept injection following study treatment administration at Week 8 were censored at their date of last visit (those who completed) or date of last contact (those who discontinued the study early).
Measured: From Week 8 to Week 56
Number of Aflibercept Intravitreal Injections up to Week 56 (Including Loading Dose)
Normalized number of aflibercept injections including loading dose was calculated as (number of aflibercept injections received plus all loading doses received) / (time within study period in months), multiplied by 6 months (Week 32) or 12 months (Week 56).
Measured: Weeks 32 and 56
Mean Change From Baseline in Central Subfield Thickness (CST) by Spectral-Domain - Optical Coherence Tomography (SD-OCT) up to Week 56
The SD-OCT assessments in study eye was taken by a study-certified OCT technician according to the standardized procedures described in the Study Manual. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Measured: Baseline (Day 1) and Weeks 32 and 56
Change From Baseline in Height of Subretinal Fluid by Spectral-Domain - Optical Coherence Tomography up to Week 56
The SD-OCT assessments in study eye was taken by a study-certified OCT technician according to the standardized procedures described in the Study Manual. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Measured: Baseline (Day 1) and Weeks 32 and 56
Percentage of Subjects With No Detectable Intraretinal Fluid/Cysts in the Central Subfield up to Week 56
The percentage of subjects with no detectable intraretinal fluid/cysts in the central subfield were summarized by scheduled visit and for any time post-baseline visits. Intraretinal fluid was assessed for the categories 'Absent', 'Present, not clinically significant', 'Present, clinically significant' and 'Not Done'. If intraretinal fluid assessment at any scheduled visit fell under the category 'Absent or Present, not clinically significant', then it was considered as no detectable intraretinal fluid in that scheduled visit.
Measured: Weeks 32 and 56
Change From Baseline in Total Lesion Area by Fluorescein Angiography (FA) up to Week 56
The total lesion area was defined as the active vascular component [classic and occult choroidal neovascularization (CNV)] and the non-vascular/fibrotic component (fibrosis, serous pigment epithelial detachment, elevated blocking hemorrhage or hyperplastic pigment). Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Measured: Baseline (Day 1) and Weeks 32 and 56
Change From Baseline in Total Choroidal Neovascularization Area by Fluorescein Angiography up to Week 56
The total CNV area included the measured area of classic and occult components. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
Measured: Baseline (Day 1) and Weeks 32 and 56
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Blood samples were collected at the study visits to determine the EYP-1901 and its main metabolite concentrations.
Measured: Up to Week 56
Ocular Exposure to EYP-1901 Measured Through Aqueous Humor (AH) Levels up to Week 32
The AH samples were collected at the study visits to determine the EYP-1901 and its main metabolite concentrations.
Measured: Up to Week 32
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events up to Week 56
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational or marketed (medicinal) product and that does not necessarily have a causal relationship with the product. An serious AE is any AE that results in one of the following outcomes: death; life-threatening; requires in-patient hospitalization; results in a persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. The TEAEs are AEs that occur after the first dose of study treatment.
administration.
Measured: From the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start30 Jun 2022
- Primary completion29 Nov 2023
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381948
- Sponsor's protocol ID
- EYP-1901-201
- Acronym
- DAVIO2
- Status last verified
- Oct 2025
- First submitted
- 9 May 2022
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Wet AMD
- ClinicalTrials.gov ID
- NCT05381948
- Acronym / sponsor ID
- DAVIO2 / EYP-1901-201
- Conditions
- Wet Age-related Macular Degeneration
- Keywords
- wAMD, EYP-1901, EyePoint
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Posted 2 Oct 2025
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 2 randomized, double -masked study comparing the efficacy of EYP-1901 at 2 dose levels: 2060 microgram (mcg) and 3090 mcg against aflibercept.
Detailed description
This study is evaluating the 2 doses of EYP-1901 against aflibercept in a randomized study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EYP-1901 2060 mcg | Experimental | Drug: EYP-1901EYP-1901 2060 mcg, single dose |
| EYP-1901 3090 mcg | Experimental | Drug: EYP-1901EYP-1901 3090 mcg, single dose |
| Aflibercept | Active comparator | Drug: Aflibercept 2mg/0.05mL Inj,OphAflibercept 2 milligram (mg) [0.05 milliliter (mL)] every 8 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documented diagnosis of wAMD in the study eye, with disease onset any time prior to the Screening Visit.
- Documented anatomical response (that is, reduction in fluid on [spectral-domain - optical coherence tomography (SD-OCT)] to previous intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections in the study eye prior to the Screening Visit.
- Previously treated with at least 2 anti-VEGF intravitreal injections (that is, bevacizumab, ranibizumab, aflibercept or faricimab) for wAMD per standard of care in the study eye within 6 months prior to the Screening Visit.
- Received previous anti-VEGF therapy 2 to 5 weeks (14 to 35 days) in the study eye prior to Screening Visit, but no more than 42 days prior to randomization to study treatment on Day 1.
- Best corrected visual acuity (BCVA) early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 35 letters (20/200 Snellen equivalent) to 85 letters (20/20 Snellen equivalent) in the study eye at the Screening Visit and on Day 1.
Key exclusion criteria (50 listed)
- History of pars plana vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye.
- Prior treatment with Visudyne® (verteporfin), external beam radiation therapy, or transpupillary thermotherapy in the study eye.
- Previous treatment with intravitreal corticosteroid injection or device implantation in the study eye.
- Previous focal laser photocoagulation used for AMD treatment in the study eye.
- Total choroidal neovascularization (CNV) lesion size >12 disc areas [30.5 millimeter square (mm^2)] as assessed by fluorescein angiography (FA) in the study eye at the Screening Visit.
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 2060 mcg, EYP-1901 3090 mcg |
| Aflibercept 2mg/0.05mL Inj,OphAlso: EyleaIntravitreal Injection | Drug | Aflibercept |
Primary outcome
Average Change in Best Corrected Visual Acuity (BCVA) From Baseline Averaged Over Weeks 28 and 32
Time frame: Baseline (Day 1) and Weeks 28 and 32
The BCVA was measured according to the standard procedure originally developed for Early Treatment Diabetic Retinopathy Study (ETDRS). The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure. Baseline was defined as the last non-missing measurement before the initiation of study treatment.
13 secondary outcomes
Change From Baseline in Best Corrected Visual Acuity up to Week 56
Time frame: Baseline (Day 1) and Weeks 32 and 56
Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56
Time frame: Baseline (Day 1) and Weeks 32 and 56
Percentage of Subjects Not Receiving Supplemental Injection of Aflibercept up to Week 56
Time frame: Weeks 32 and 56
Median Time to First Supplemental Aflibercept Injection in the Study Eye Following the EYP-1901 Dose at Week 8
Time frame: From Week 8 to Week 56
Number of Aflibercept Intravitreal Injections up to Week 56 (Including Loading Dose)
Time frame: Weeks 32 and 56
Mean Change From Baseline in Central Subfield Thickness (CST) by Spectral-Domain - Optical Coherence Tomography (SD-OCT) up to Week 56
Time frame: Baseline (Day 1) and Weeks 32 and 56
Change From Baseline in Height of Subretinal Fluid by Spectral-Domain - Optical Coherence Tomography up to Week 56
Time frame: Baseline (Day 1) and Weeks 32 and 56
Percentage of Subjects With No Detectable Intraretinal Fluid/Cysts in the Central Subfield up to Week 56
Time frame: Weeks 32 and 56
Change From Baseline in Total Lesion Area by Fluorescein Angiography (FA) up to Week 56
Time frame: Baseline (Day 1) and Weeks 32 and 56
Change From Baseline in Total Choroidal Neovascularization Area by Fluorescein Angiography up to Week 56
Time frame: Baseline (Day 1) and Weeks 32 and 56
Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56
Time frame: Up to Week 56
Ocular Exposure to EYP-1901 Measured Through Aqueous Humor (AH) Levels up to Week 32
Time frame: Up to Week 32
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events up to Week 56
Time frame: From the study drug administration (Day 1) up to end of the study, approximately 56 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
Wet Age-related Macular Degeneration
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
RecruitingPhase 1
Safety and Efficacy Study of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).
nAMD
RecruitingPhase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration
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.
67 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EYP-1901 and Aflibercept 2mg/0.05mL Inj,Oph in people with Wet Age-related Macular Degeneration, run by EyePoint Pharmaceuticals, Inc. at 67 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 8 inclusion and 50 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: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) From Baseline Averaged Over Weeks 28 and 32 (time frame: Baseline (Day 1) and Weeks 28 and 32). 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 15 Oct 2025.