Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)

NCT05381948 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EYP-1901-201
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 67

Brief 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.

Conditions

Wet Age-related Macular Degeneration

Keywords

wAMD; EYP-1901; EyePoint

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 1) and Weeks 28 and 32

Secondary Outcomes (13)

• Change From Baseline in Best Corrected Visual Acuity up to Week 56

  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

  Baseline (Day 1) and Weeks 32 and 56

• Percentage of Subjects Not Receiving Supplemental Injection of Aflibercept up to Week 56

  Weeks 32 and 56

• Median Time to First Supplemental Aflibercept Injection in the Study Eye Following the EYP-1901 Dose at Week 8

  From Week 8 to Week 56

• Number of Aflibercept Intravitreal Injections up to Week 56 (Including Loading Dose)

  Weeks 32 and 56

Study Arms (3)

EYP-1901 2060 mcg

EXPERIMENTAL

EYP-1901 2060 mcg, single dose

Drug: EYP-1901

EYP-1901 3090 mcg

EXPERIMENTAL

EYP-1901 3090 mcg, single dose

Drug: EYP-1901

Aflibercept

ACTIVE COMPARATOR

Aflibercept 2 milligram (mg) \[0.05 milliliter (mL)\] every 8 weeks

Drug: Aflibercept 2mg/0.05mL Inj,Oph

Interventions

EYP-1901 DRUG

Intravitreal Injection

EYP-1901 2060 mcg; EYP-1901 3090 mcg

Aflibercept 2mg/0.05mL Inj,Oph DRUG

Intravitreal Injection

Also known as: Eylea

Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• EyePoint Pharmaceuticals, Inc.: lead

Study Sites (67)

EyePoint Investigative Site

Phoenix, Arizona, 85053, United States

Location

EyePoint Investigative Site

Springdale, Arkansas, 72762, United States

Location

EyePoint Investigative Site

Beverly Hills, California, 90211, United States

Location

EyePoint Investigative Site

Campbell, California, 95008, United States

Location

EyePoint Investigative Site

Encino, California, 91436, United States

Location

EyePoint Investigative Site

Fullerton, California, 92835, United States

Location

EyePoint Investigative Site

Glendale, California, 91203, United States

Location

EyePoint Investigative Site

Huntington Beach, California, 92647, United States

Location

EyePoint Investigative Site

Irvine, California, 92697, United States

Location

EyePoint Investigative Site

Pasadena, California, 91107, United States

Location

EyePoint Investigative Site

Poway, California, 92064, United States

Location

EyePoint Investigative Site

Redlands, California, 92373, United States

Location

EyePoint Investigative Site

Sacramento, California, 95825, United States

Location

EyePoint Investigative Site

Walnut Creek, California, 94598, United States

Location

EyePoint Investigative Site

Lakewood, Colorado, 80228, United States

Location

EyePoint Investigative Site

Clearwater, Florida, 33761, United States

Location

EyePoint Investigative Site

Coral Springs, Florida, 33067, United States

Location

EyePoint Investigative Site

Lakeland, Florida, 33805, United States

Location

EyePoint Investigative Site

Melbourne, Florida, 32901, United States

Location

EyePoint Investigative Site

Miami, Florida, 33143, United States

Location

EyePoint Investigative Site

Pensacola, Florida, 32503, United States

Location

EyePoint Investigative Site

Sarasota, Florida, 34239, United States

Location

EyePoint Investigative Site

St. Petersburg, Florida, 33711, United States

Location

EyePoint Investigative Site

Tampa, Florida, 33609, United States

Location

EyePoint Investigative Site

Winter Haven, Florida, 33880, United States

Location

EyePoint Investigative Site

Marietta, Georgia, 30060, United States

Location

EyePoint Investigative Site

‘Aiea, Hawaii, 96701, United States

Location

EyePoint Investigative Site

Chicago, Illinois, 60616, United States

Location

EyePoint Investigative Site

Lemont, Illinois, 60439, United States

Location

EyePoint Investigative Site

Carmel, Indiana, 46290, United States

Location

EyePoint Investigative Site

West Des Moines, Iowa, 50266, United States

Location

EyePoint Investigative Site

Baltimore, Maryland, 21209, United States

Location

EyePoint Investigative Site

Hagerstown, Maryland, 21740, United States

Location

EyePoint Investigative Site

Owings Mills, Maryland, 21117, United States

Location

EyePoint Investigative Site

Boston, Massachusetts, 02114, United States

Location

EyePoint Investigative Site

Springfield, Massachusetts, 01107, United States

Location

EyePoint Investigative Site

Grand Rapids, Michigan, 49446, United States

Location

EyePoint Investigative Site

Saint Louis, Michigan, 55416, United States

Location

EyePoint Investigative Site

St Louis, Missouri, 63128, United States

Location

EyePoint Investigative Site

Reno, Nevada, 89502, United States

Location

EyePoint Investigative Site

Teaneck, New Jersey, 07666, United States

Location

EyePoint Investigative Site

Great Neck, New York, 11021, United States

Location

EyePoint Investigative Site

Hauppauge, New York, 11788, United States

Location

EyePoint Investigative Site

Liverpool, New York, 13088, United States

Location

EyePoint Investigative Site

Shirley, New York, 11967, United States

Location

EyePoint Investigative Site

Asheville, North Carolina, 28803, United States

Location

EyePoint Investigative Site

Wake Forest, North Carolina, 27587, United States

Location

EyePoint Investigative Site

Eugene, Oregon, 97401, United States

Location

EyePoint Investigative Site

Portland, Oregon, 97239, United States

Location

EyePoint Investigative Site

Springfield, Oregon, 97488, United States

Location

EyePoint Investigative Site

Charleston, South Carolina, 29414, United States

Location

EyePoint Investigative Site

West Columbia, South Carolina, 29169, United States

Location

EyePoint Investigative Site

Germantown, Tennessee, 38138, United States

Location

EyePoint Investigative Site

Nashville, Tennessee, 37203, United States

Location

EyePoint Investigative Site

Abilene, Texas, 79606, United States

Location

EyePoint Investigative Sites

Austin, Texas, 78750, United States

Location

EyePoint Investigative Site

Dallas, Texas, 75231, United States

Location

EyePoint Investigative Sites

Houston, Texas, 77025, United States

Location

EyePoint Investigative Site

McAllen, Texas, 78503, United States

Location

EyePoint Investigative Site

Plano, Texas, 75075, United States

Location

EyePoint Investigative Site

San Antonio, Texas, 78240, United States

Location

EyePoint Investigative Site

The Woodlands, Texas, 77384, United States

Location

EyePoint Investigative Site

Salt Lake City, Utah, 84107, United States

Location

EyePoint Investigative Site

Fairfax, Virginia, 22031, United States

Location

EyePoint Investigative Site

Lynchburg, Virginia, 24502, United States

Location

EyePoint Investigative Site

Warrenton, Virginia, 20186, United States

Location

EyePoint Investigative Site

Silverdale, Washington, 98383, United States

Location

MeSH Terms

Interventions

aflibercept

Limitations and Caveats

For the events of endophthalmitis in the Serious Adverse Events (SAE) table, none were considered related to EYP-1901. In the aflibercept treatment group, these events were considered related to the injection procedure or were not treatment-related. In the EYP-1901 treatment group, these events were considered related to the supplemental injection procedure (with aflibercept), the paracentesis for aqueous humor collection, or were not treatment-related.

Results Point of Contact

• Title: Ramiro Ribeiro, MD, PhD
• Organization: EyePoint Pharmaceuticals, Inc.

rribeiro@eyepointpharma.com

908-440-0979

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 19, 2022
• Study Start: June 30, 2022
• Primary Completion: November 29, 2023
• Study Completion: April 24, 2024
• Last Updated: October 15, 2025
• Results First Posted: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (67)