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

Sponsor
EyePoint Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04747197
Collaborator
(none)
17
Enrollment
11
Locations
3
Arms
15.6
Actual Duration (Months)
1.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 20, 2021
Actual Primary Completion Date :
May 11, 2022
Actual Study Completion Date :
May 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: EYP-1901 440 ug

EYP-1901 440 ug, single dose

Drug: EYP-1901
Intravitreal injection
Experimental: EYP-1901 2060 ug

EYP-1901 2060 ug, single dose

Drug: EYP-1901
Intravitreal injection
Experimental: EYP-1901 3090 ug

EYP-1901 3090 ug, single dose

Drug: EYP-1901
Intravitreal injection

Outcome Measures

Primary Outcome Measures

  1. Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs) [Week 48]

Other Outcome Measures

  1. Mean change in central retinal thickness on optical coherence tomography (OCT) [Baseline, Week 48]

  2. Mean change in best corrected visual acuity (BCVA) [Baseline, Week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 EyePoint Investigational Site Melbourne Florida United States 32901
6 EyePoint Investigational Site Saint Petersburg Florida United States 33711
7 EyePoint Investigational Site Springfield Massachusetts United States 01107
8 EyePoint Investigative Site Asheville North Carolina United States 28803
9 EyePoint Investigational Site Philadelphia Pennsylvania United States 19107
10 EyePoint Investigational Site Abilene Texas United States 79606
11 EyePoint Investigational Site Austin Texas United States 78705

Sponsors and Collaborators

  • EyePoint Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EyePoint Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT04747197
Other Study ID Numbers:
  • EYP-1901-001
First Posted:
Feb 10, 2021
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by EyePoint Pharmaceuticals, Inc.
wAMD
EYP-1901
EyePoint
DAVIO
Additional relevant MeSH terms:
Macular Degeneration

Study Results

No Results Posted as of Jul 26, 2022