Wet Age-related Macular Degeneration
Conditions
Keywords
wAMD, EYP-1901, EyePoint, DAVIO
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)
Interventions
DRUGEYP-1901
Intravitreal injection
Sponsors
EyePoint Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs) | Week 48 | Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in best corrected visual acuity (BCVA) by EDTRS | Baseline, Week 48 | Mean change from Baseline in BCVA in the Study Eye |
| Mean change in central subfield thickness (CST) | Baseline, Week 48 | Mean change from Baseline in CST measured in microns by Spectral-domain - optical coherence tomography (OCT) assessments by a study-certified OCT technician in the study eye |
Countries
United States
Outcome results
None listed