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

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1 open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of a single injections of EYP-1901 at three dose levels: 440 µg, 2060 µg and 3090 µg

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EyePoint; EyePoint Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Subjects diagnosed with wet Age-Related Macular Degeneration (wAMD), in the study eye, within 18 months before the Screening Visit.

• 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-VEGF treatment in the study eye.

• Best-corrected visual acuity (BCVA) using ETDRS charts of 25 letters (20/320 Snellen equivalent) to 75 letters (20/32 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.