First in Human Study to Evaluate the Safety and Tolerability of EYP-1901 in Patients With Wet Age Related Macular Degeneration (wAMD)
A Phase 1, Multicenter, Prospective, Open-Label, Dose Escalation Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), in Subjects With Wet AMD
1 other identifier
interventional
17
1 country
11
Brief Summary
Phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single dose injections of EYP-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg in subjects with Wet Age Related Macular Degeneration (wAMD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2021
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2021
CompletedFirst Submitted
Initial submission to the registry
February 6, 2021
CompletedFirst Posted
Study publicly available on registry
February 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2022
CompletedJuly 19, 2023
June 1, 2023
1.3 years
February 6, 2021
July 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs)
Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population
Week 48
Secondary Outcomes (2)
Change in best corrected visual acuity (BCVA) by EDTRS
Baseline, Week 48
Mean change in central subfield thickness (CST)
Baseline, Week 48
Study Arms (3)
440 ug, single dose
EXPERIMENTALEYP-1901 440 ug, single dose
2060 ug, single dose
EXPERIMENTALEYP-1901 2060 ug, single dose
3090 ug, single dose
EXPERIMENTALEYP-1901 3090 ug, single dose
Interventions
Eligibility Criteria
You may qualify if:
- Subjects diagnosed with wet Age-Related Macular Degeneration (wAMD), in the study eye.
- Subject must have received ≥3 prior injections with the same anti-VEGF product: bevacizumab, ranibizumab, or aflibercept) in the 6 months prior to the Screening Visit, in the study eye.
- Demonstrated response to the intravitreal anti-vascular endothelial growth factor (VEGF) treatment in the study eye.
- Best-corrected visual acuity (BCVA) using ETDRS charts of 25 letters (20/320 Snellen equivalent) to 85 letters (20/20 Snellen equivalent).
You may not qualify if:
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye.
- Subfoveal fibrosis or scarring \>50% of the total lesion, or atrophy in the study eye, confirmed by central reading center.
- Choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia that would compromise vision in the study eye, confirmed by central reading center.
- Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma) that, in the opinion of the Investigator, would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of the study results.
- Active intraocular inflammation (grade trace or above) in the study eye.
- History of rhegmatogenous retinal detachment or treatment for retinal detachment or macular hole (stage 3 or 4) in the study eye.
- History of idiopathic or autoimmune-associated uveitis in either eye.
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
EyePoint Investigational Site
Phoenix, Arizona, 85053, United States
EyePoint Investigational Site
Beverly Hills, California, 90211, United States
EyePoint Investigative Site
Mountain View, California, 94040, United States
EyePoint Investigational Site
Oxnard, California, 93036, United States
EyePoint Investigational Site
Melbourne, Florida, 32901, United States
EyePoint Investigational Site
St. Petersburg, Florida, 33711, United States
EyePoint Investigational Site
Springfield, Massachusetts, 01107, United States
EyePoint Investigative Site
Asheville, North Carolina, 28803, United States
EyePoint Investigational Site
Philadelphia, Pennsylvania, 19107, United States
EyePoint Investigational Site
Abilene, Texas, 79606, United States
EyePoint Investigational Site
Austin, Texas, 78705, United States
Related Publications (1)
Patel S, Storey PP, Barakat MR, Hershberger V, Bridges WZ Jr, Eichenbaum DA, Lally DR, Boyer DS, Bakri SJ, Roy M, Paggiarino DA. Phase I DAVIO Trial: EYP-1901 Bioerodible, Sustained-Delivery Vorolanib Insert in Patients With Wet Age-Related Macular Degeneration. Ophthalmol Sci. 2024 Apr 9;4(5):100527. doi: 10.1016/j.xops.2024.100527. eCollection 2024 Sep-Oct.
PMID: 38881599DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2021
First Posted
February 10, 2021
Study Start
January 20, 2021
Primary Completion
May 11, 2022
Study Completion
May 11, 2022
Last Updated
July 19, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share