First in Human Study to Evaluate the Safety and Tolerability of EYP-1901 in Patients With Wet Age Related Macular Degeneration (wAMD)

EyePoint Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Wet Age-related Macular Degeneration

Treatments: Drug: EYP-1901

Study type: Interventional

Funder types: Industry

Identifiers

NCT04747197

EYP-1901-001

Details and patient eligibility

About

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)

Enrollment: 17 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

17 participants in 3 patient groups

440 ug, single dose

Experimental group

Description:

EYP-1901 440 ug, single dose

Treatment:

Drug: EYP-1901

2060 ug, single dose

Experimental group

Description:

EYP-1901 2060 ug, single dose

Treatment:

Drug: EYP-1901

3090 ug, single dose

Experimental group

Description:

EYP-1901 3090 ug, single dose

Treatment:

Drug: EYP-1901