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

Completed · Phase 2

Conditions studied: Wet Age-related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT05381948

Run by

EyePoint Pharmaceuticals, Inc.

People needed

161

Starts

2022-06-30

Expected to finish

2024-04-24

Last updated by the study team

2025-10-15

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• EyePoint Investigative Site — Phoenix, Arizona, United States
• EyePoint Investigative Site — Springdale, Arkansas, United States
• EyePoint Investigative Site — Beverly Hills, California, United States
• EyePoint Investigative Site — Campbell, California, United States
• EyePoint Investigative Site — Encino, California, United States
• EyePoint Investigative Site — Fullerton, California, United States
• EyePoint Investigative Site — Glendale, California, United States
• EyePoint Investigative Site — Huntington Beach, California, United States
• EyePoint Investigative Site — Irvine, California, United States
• EyePoint Investigative Site — Pasadena, California, United States
• EyePoint Investigative Site — Poway, California, United States
• EyePoint Investigative Site — Redlands, California, United States
• EyePoint Investigative Site — Sacramento, California, United States
• EyePoint Investigative Site — Walnut Creek, California, United States
• EyePoint Investigative Site — Lakewood, Colorado, United States
• EyePoint Investigative Site — Clearwater, Florida, United States
• EyePoint Investigative Site — Coral Springs, Florida, United States
• EyePoint Investigative Site — Lakeland, Florida, United States
• EyePoint Investigative Site — Melbourne, Florida, United States
• EyePoint Investigative Site — Miami, Florida, United States
• EyePoint Investigative Site — Pensacola, Florida, United States
• EyePoint Investigative Site — Sarasota, Florida, United States
• EyePoint Investigative Site — St. Petersburg, Florida, United States
• EyePoint Investigative Site — Tampa, Florida, United States
• EyePoint Investigative Site — Hagerstown, Maryland, United States

Full record on ClinicalTrials.gov

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