Status:
COMPLETED
First in Human Study to Evaluate the Safety and Tolerability of EYP-1901 in Patients With Wet Age Related Macular Degeneration (wAMD)
Lead Sponsor:
EyePoint Pharmaceuticals, Inc.
Conditions:
Wet Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
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 309...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04747197
Start Date
January 20 2021
End Date
May 11 2022
Last Update
July 19 2023
Active Locations (11)
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1
EyePoint Investigational Site
Phoenix, Arizona, United States, 85053
2
EyePoint Investigational Site
Beverly Hills, California, United States, 90211
3
EyePoint Investigative Site
Mountain View, California, United States, 94040
4
EyePoint Investigational Site
Oxnard, California, United States, 93036