Clinical trial NCT04747197: First in Human Study to Evaluate the Safety and Tolerability of EYP-1901 in Patients With Wet Age Related Macular Degeneration (wAMD)
Official title: A Phase 1, Multicenter, Prospective, Open-Label, Dose Escalation Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), in Subjects With Wet AMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Wet Age-related Macular Degeneration
Keywords: wAMD
EYP-1901
EyePoint
DAVIO
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 17
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs)
timeFrame: Week 48
Secondary outcomes:
measure: Change in best corrected visual acuity (BCVA) by EDTRS
timeFrame: Baseline, Week 48
measure: Mean change in central subfield thickness (CST)
timeFrame: Baseline, Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: EyePoint Investigational Site
state: Arizona
city: Beverly Hills
country: United States
facility: EyePoint Investigational Site
state: California
city: Mountain View
country: United States
facility: EyePoint Investigative Site
state: California
city: Oxnard
country: United States
facility: EyePoint Investigational Site
state: California
city: Melbourne
country: United States
facility: EyePoint Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: EyePoint Investigational Site
state: Florida
city: Springfield
country: United States
facility: EyePoint Investigational Site
state: Massachusetts
city: Asheville
country: United States
facility: EyePoint Investigative Site
state: North Carolina
city: Philadelphia
country: United States
facility: EyePoint Investigational Site
state: Pennsylvania
city: Abilene
country: United States
facility: EyePoint Investigational Site
state: Texas
city: Austin
country: United States
facility: EyePoint Investigational Site
state: Texas
Study officials:
References: