A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept(Eylea) in Subjects with Wet AMD
Principle Investigator: Gordon Crabtree
Study Coordinators: Chris Smith (608-263-7169) and Nicole Boone (608-265-4734)
- Treatment naïve with wet age-related macular degeneration (wAMD) who meet the study eligibility criteria will be randomly assigned to treatment with EYP-1901 2686 µg (2 inserts) or aflibercept 2 mg (0.05 mL).
- Sham injections will be used for all treatment groups, according to a double-dummy design, to maintain masking.
- Subjects in the EYP-1901 treatment group will receive a dose of aflibercept at Baseline (Day 1) and Week 4. At Week 8, subjects will receive a dose of aflibercept and 30 minutes (±10 minutes) later an EYP-1901 dose. At Weeks 32, 56, and 80, subjects in the EYP-1901 treatment group will receive the EYP-1901 dose only. Subjects will receive sham injections on Weeks 16, 24, 40, 48, 64, 72, and 88.
- Subjects in the aflibercept treatment group will receive a dose of aflibercept at Baseline (Day 1) and Week 4. At Week 8, they will receive a dose of aflibercept followed by a sham injection 30 minutes (±10 minutes) later. After Week 8, aflibercept dosing will occur at a frequency of once every 8 weeks.
Ocular inclusion criteria for Study Eye:
This study will enroll treatment naïve subjects
- BCVA by 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).
- Decrease in BCVA determined to be primarily the result of wAMD in the study eye.
- Documented diagnosis of wAMD in the study eye, with onset of disease that began at any time prior to the Screening Visit.
- Active subfoveal CNV due to wAMD, including juxtafoveal lesions that affect the fovea, as defined by presence of fluid (intraretinal or subretinal) affecting the central subfield as measured by SD-OCT. The central subfield is defined as a circle with a 1 mm diameter, centered on the fovea.
- Total CNV lesion size (including blood, atrophy, fibrosis, and neovascularization) of ≤ 9-disc areas as assessed by FA.
- Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area
Ocular Exclusion Criteria for the Study Eye Only:
- Central subfield retinal thickness (CST) >500 µm at Screening Visit or Day 1 (Baseline).
- Fibrosis >50% of the total lesion.
- Subfoveal fibrosis, atrophy, or scarring in the center subfield.
- Subretinal hemorrhage in the subfoveal/juxtafoveal location or hemorrhage greater than 1 disc area if located 400 µm at any point within 3 mm of the foveal center at either the Screening Visit or Baseline (Day 1).
- Retinal pigment epithelial tear at the Screening Visit or Baseline (Day 1).
- RPED thickness >400 µm at any point within 3 mm of the foveal center at either the Screening Visit or Baseline (Day 1)
- Presence of signs indicative of polypoidal choroidal vasculopathy (PCV) as assessed by the Central Reading Center.
- CNV caused by ocular histoplasmosis, pathological myopia, angioid streaks, choroidal rupture, uveitis, and trauma.
- History of pars plana vitrectomy surgery, submacular surgery, or other surgical intervention for wAMD.
- Previous focal laser photocoagulation used for wAMD treatment, including treatment with Visudyne® (verteporfin).
- Previous use of intraocular brolucizumab 12 months prior to screening.
- Previous use of EYP-1901 or Susvimo ocular implant.
- Previous or ongoing treatment with complement inhibitors (Syfovre [pegcetacoplan IVT] and Izervay [avacincaptad pegol]) for GA
Contact Chris Smith, 608-263-7169, or Nicole Boone, 608-265-4734, with questions.
For more information about this study visit: