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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)

Primary Purpose

Wet Age-related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EYP-1901
Sponsored by
EyePoint Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Age-related Macular Degeneration focused on measuring wAMD, EYP-1901, EyePoint, DAVIO

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • EyePoint Investigational Site
  • EyePoint Investigational Site
  • EyePoint Investigative Site
  • EyePoint Investigational Site
  • EyePoint Investigational Site
  • EyePoint Investigational Site
  • EyePoint Investigational Site
  • EyePoint Investigative Site
  • EyePoint Investigational Site
  • EyePoint Investigational Site
  • EyePoint Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

440 ug, single dose

2060 ug, single dose

3090 ug, single dose

Arm Description

EYP-1901 440 ug, single dose

EYP-1901 2060 ug, single dose

EYP-1901 3090 ug, single dose

Outcomes

Primary Outcome Measures

Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs)
Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population

Secondary Outcome Measures

Change in best corrected visual acuity (BCVA) by EDTRS
Mean change from Baseline in BCVA in the Study Eye
Mean change in central subfield thickness (CST)
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

Full Information

First Posted
February 6, 2021
Last Updated
July 18, 2023
Sponsor
EyePoint Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04747197
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
May 11, 2022 (Actual)
Study Completion Date
May 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyePoint Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Age-related Macular Degeneration
Keywords
wAMD, EYP-1901, EyePoint, DAVIO

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
440 ug, single dose
Arm Type
Experimental
Arm Description
EYP-1901 440 ug, single dose
Arm Title
2060 ug, single dose
Arm Type
Experimental
Arm Description
EYP-1901 2060 ug, single dose
Arm Title
3090 ug, single dose
Arm Type
Experimental
Arm Description
EYP-1901 3090 ug, single dose
Intervention Type
Drug
Intervention Name(s)
EYP-1901
Intervention Description
Intravitreal injection
Primary Outcome Measure Information:
Title
Incidence of ocular (study eye) and systemic treatment emergent adverse events (TEAEs)
Description
Number of ocular (study eye) and systemic TEAEs during the treatment period - Intent-to-Treat (ITT) Population
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Change in best corrected visual acuity (BCVA) by EDTRS
Description
Mean change from Baseline in BCVA in the Study Eye
Time Frame
Baseline, Week 48
Title
Mean change in central subfield thickness (CST)
Description
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
Time Frame
Baseline, Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
EyePoint Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
EyePoint Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
EyePoint Investigative Site
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
EyePoint Investigational Site
City
Oxnard
State/Province
California
ZIP/Postal Code
93036
Country
United States
Facility Name
EyePoint Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
EyePoint Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
EyePoint Investigational Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
EyePoint Investigative Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
EyePoint Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
EyePoint Investigational Site
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
EyePoint Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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