Study of EYP-1901 in Patients With Nonproliferative Diabe... | NCT05383209 | Trialant
NCT05383209
Sponsor
EyePoint Pharmaceuticals, Inc.
Status
Completed
Last Update Posted
Aug 15, 2025Actual
Enrollment
77Actual
Phase
Phase 2
Conditions
Nonproliferative Diabetic Retinopathy
Interventions
EYP-1901
Sham IVT
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05383209
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
EYP-1901-204
Secondary IDs
Not provided
Brief Title
Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)
Official Title
A Phase 2, Multicenter, Prospective, Double-masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Sham for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
Acronym
Not provided
Organization
EyePoint Pharmaceuticals, Inc.INDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 28, 2022Actual
Primary Completion Date
Feb 12, 2024Actual
Completion Date
May 6, 2024Actual
First Submitted Date
May 10, 2022
First Submission Date that Met QC Criteria
May 16, 2022
First Posted Date
May 20, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Jul 9, 2025
Results First Submitted that Met QC Criteria
Jul 9, 2025
Results First Posted Date
Jul 28, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 13, 2025
Last Update Posted Date
Aug 15, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
EyePoint Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A prospective, randomized, double-masked study that evaluated the ocular efficacy and safety of two doses of the EYP-1901 intravitreal (IVT) insert compared to sham.
Detailed Description
This study evaluated the ocular efficacy and safety of two doses of the EYP-1901 IVT insert compared to sham using a randomized double-masked trial design.
Conditions Module
Conditions
Nonproliferative Diabetic Retinopathy
Keywords
NPDR
EYP-1901
EyePoint
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
77Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
EYP-1901 2060 ug
Experimental
EYP-1901 2060 ug; single injection
Drug: EYP-1901
EYP-1901 3090 ug
Experimental
EYP-1901 3090 ug; single injection
Drug: EYP-1901
Sham IVT
Sham Comparator
Sham IVT; single injection
Other: Sham IVT
Interventions
Name
Type
Description
Arm Group Labels
Other Names
EYP-1901
Drug
EYP-1901 will be administered to the study eye by a single injection through the pars plana using a pre-loaded applicator with a 22-gauge needle. Each EYP-1901 IVT insert has been designed to deliver vorolanib into the vitreous humor for approximately 6 to 9 months.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 36
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Week 36 from baseline.
Baseline (Day 1) and Week 36
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 24 and Week 48
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity levels 47 (moderately severe NPDR) and 53 (severe NPDR) at Weeks 24 and 48 from baseline.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must have a hemoglobin A1c <=12%
Study eye with moderately severe to severe Non proliferative Diabetic Retinopathy (NPDR) (based on the Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53)
Best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of >=69 letters (approximate Snellen equivalent of 20/40 or better).
Exclusion Criteria:
Presence of any active Center involved-diabetic macular edema in the study eye as determined by the Investigator on clinical examination, or within the central subfield thickness (CST) of the study eye, with a CST threshold greater than 320 microns.
Any evidence or documented history of prior focal or grid laser photocoagulation or any pan-retinal photocoagulation (PRP) in the study eye in the last 12 months.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Ramiro Ribeiro, MD, PhD
EyePoint Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
EyePoint Investigative Site
Phoenix
Arizona
85020
United States
EyePoint Investigative Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
This study consists of a screening period (up to 30 days) and treatment period (48 weeks). A total of 77 subjects were enrolled in the study.
Recruitment Details
This Phase 2 prospective, randomized, double-masked study was conducted in adult subjects with NPDR at 25 sites in the United States between 28 September 2022 and 06 May 2024.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
FG001
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 microgram (mcg) IVT injection on Day 1.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 31, 2023
Jul 9, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
EYP-1901 2060 ug
EYP-1901 3090 ug
Vorolanib
Sham IVT
Other
Sham injections will be used to maintain masking of investigational EYP-1901 therapy for study subjects.
Sham IVT
Baseline (Day 1), Week 24, and Week 48
Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced PDR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Weeks 24, 36 and 48 from baseline.
Baseline (Day 1) and Weeks 24, 36 and 48
Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced PDR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Weeks 24, 36 and 48 from baseline.
Baseline (Day 1) and Weeks 24, 36 and 48
Percentage of Subjects Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Weeks 24, 36 and 48
The vision threatening complications in the study eye due to diabetic retinopathy were indicated by the presence of "Vitreous hemorrhage" or the presence of "Tractional retinal detachment" reported on the Ocular Examination - Dilated Ophthalmoscopy CRF (PDR events), and "Neovascularization for the Iris" answered as "Yes" or "Neovascularization for the Angle" answered as "Yes" per the Ocular Examination - Slit Lamp Biomicroscopy CRF (anterior segment neovascularization (ASNV) events).
Weeks 24, 36 and 48
Percentage of Subjects Who Developed Center Involved-Diabetic Macular Edema (CI-DME) at Weeks 24, 36 and 48
The CI-DME in the study eye occurred when a treatment emergent adverse event (TEAE) with a mapped preferred term of 'Cystoid macular oedema', 'Diabetic retinal oedema', or 'Macular oedema' occurred in the study eye, in combination with the temporally closest centrally read custom algorithm CST measurement being greater than or equal to 320 microns.
Weeks 24, 36 and 48
Time to Develop Any Neovascular Vision Threatening Complication (PDR/ASNV) at Weeks 24, 36 and 48
Time to develop any PDR/ASNV was computed as the date of the first development of PDR/ASNV in the study eye minus the date of study treatment administration plus 1 day, divided by 7 days per week.
Weeks 24, 36 and 48
Time to Develop CI-DME Through Weeks 24, 36 and 48
The occurrence of a CI-DME event in the study eye was identified via examination of centrally read custom algorithm CST data and adverse events.
Weeks 24, 36 and 48
Percentage of Subjects Who Received Anti-Vascular Endothelial Growth Factor (VEGF) or Additional Standard of Care Intervention Due to Ocular Diabetic Complications at Weeks 24, 36 and 48
Percentage of subjects who received anti-VEGF or additional standard of care intervention due to ocular diabetic complications in the study eye are reported. Anti-VEGF use was identified in reported concomitant medication data.
Weeks 24, 36 and 48
Percentage of Subjects Who Received PRP at Weeks 24, 36 and 48
Percentage of subjects who received PRP in the study eye, inclusive of subjects undergoing vitrectomy with endo-laser are reported.
Weeks 24, 36 and 48
Area Under the Curve (AUC) for Change From Baseline in BCVA at Weeks 24, 36 and 48
The AUC for change from baseline in BCVA in the study eye were summarized. The AUC through each time point of interest was computed using the trapezoidal rule normalized to months, with a final unit of letters.
Weeks 24, 36 and 48
Plasma Concentration of EYP-1901 and X-297 at Weeks 24, 36 and 48
Blood samples were collected at the specific visits for the Pharmacokinetic (PK) analysis of EYP-1901 and its main metabolite concentrations.
Weeks 24, 36 and 48
Number of Subjects With Ocular and Non-Ocular TEAEs and Serious TEAEs up to Week 48
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational or marketed (medicinal) product and that does not necessarily have a causal relationship with the product. A serious AE is any AE that results in one of the following outcomes: death; life-threatening; requires in-patient hospitalization; results in a persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. The TEAEs are AEs that occur after the first dose of study treatment administration.
TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
Huntington Beach
California
92647
United States
EyePoint Investigative Site
Oxnard
California
93036
United States
EyePoint Investigative Site
Palm Desert
California
92211
United States
EyePoint Investigative Site
Pasadena
California
90041
United States
EyePoint Investigative Site
Poway
California
92064
United States
EyePoint Investigative Site
Sacramento
California
95825
United States
EyePoint Investigative Site
Danbury
Connecticut
06810
United States
EyePoint Investigative Site
Clearwater
Florida
33761
United States
EyePoint Investigative Site
Melbourne
Florida
32901
United States
EyePoint Investigative Site
Miami
Florida
33143
United States
EyePoint Investigative Site
Winter Haven
Florida
33880
United States
EyePoint Investigative Site
Lemont
Illinois
60439
United States
EyePoint Investigative Site
Indianapolis
Indiana
46290
United States
EyePoint Investigative Site
Lenexa
Kansas
66215
United States
EyePoint Investigative Site
Baltimore
Maryland
21209
United States
EyePoint Investigative Site
Hagerstown
Maryland
21740
United States
EyePoint Investigative Site
Springfield
Massachusetts
01107
United States
EyePoint Investigative Site
Reno
Nevada
89502
United States
EyePoint Investigative Site
Bloomfield
New Jersey
07003
United States
EyePoint Investigative Site
Toms River
New Jersey
08755
United States
EyePoint Investigative Site
Great Neck
New York
11021
United States
EyePoint Investigative Site
Erie
Pennsylvania
16501
United States
EyePoint Investigative Site
Florence
South Carolina
29501
United States
EyePoint Investigative Site
Ladson
South Carolina
29456
United States
EyePoint Investigative Site
Rapid City
South Dakota
57701
United States
EyePoint Investigative Site
Germantown
Tennessee
38138
United States
EyePoint Investigative Site
Abilene
Texas
79606
United States
EyePoint Investigative Site
Austin
Texas
78705
United States
EyePoint Investigative Site
Houston
Texas
78240
United States
EyePoint Investigative Site
McAllen
Texas
78503
United States
EyePoint Investigative Site
Plano
Texas
75075
United States
EyePoint Investigative Site
San Antonio
Texas
78247
United States
EyePoint Investigative Site
The Woodlands
Texas
77384
United States
EyePoint Investigative Site
Lynchburg
Virginia
24502
United States
EyePoint Investigative Site
Bellevue
Washington
98004
United States
FG002
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
FG00026 subjects
FG00126 subjects
FG00225 subjects
COMPLETED
FG00021 subjects
FG00123 subjects
FG00220 subjects
NOT COMPLETED
FG0005 subjects
FG0013 subjects
FG0025 subjects
Type
Comment
Reasons
Adverse Event: Non-ocular
FG0000 subjects
FG0011 subjects
FG0020 subjects
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0024 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0021 subjects
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
Full Analysis Set (FAS) included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
BG001
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
BG002
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00026
BG00126
BG00225
BG00377
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00056.9± 11.95
BG00156.8± 11.79
BG00260.2± 9.98
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00112
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0009
BG0018
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Asian
BG0002
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 36
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Week 36 from baseline.
The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
Posted
Number
95% Confidence Interval
percentage of subjects
Baseline (Day 1) and Week 36
ID
Title
Description
OG000
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
OG001
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
OG002
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
Units
Counts
Participants
OG00020
OG00120
OG00221
Title
Denominators
Categories
Title
Measurements
OG0005.0(0.1 to 24.9)
OG0010(0.0 to 16.8)
OG0024.8(0.1 to 23.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in response percentage
-5.0
2-Sided
95
-24.9
13.4
Other
OG000
OG002
Secondary
Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 24 and Week 48
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity levels 47 (moderately severe NPDR) and 53 (severe NPDR) at Weeks 24 and 48 from baseline.
The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
Posted
Number
95% Confidence Interval
percentage of subjects
Baseline (Day 1), Week 24, and Week 48
ID
Title
Description
OG000
Sham Injection (Week 24)
Subjects received a single dose of sham IVT injection on Day 1.
OG001
Sham Injection (Week 48)
Subjects received a single dose of sham IVT injection on Day 1.
OG002
EYP-1901 2060 mcg (Week 24)
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
OG003
Secondary
Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced PDR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Weeks 24, 36 and 48 from baseline.
The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham). Only subjects analyzed at specific timepoints are reported.
Posted
Number
95% Confidence Interval
percentage of subjects
Baseline (Day 1) and Weeks 24, 36 and 48
ID
Title
Description
OG000
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
OG001
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
OG002
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
Secondary
Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced PDR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Weeks 24, 36 and 48 from baseline.
The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham). Only subjects analyzed at specific timepoints are reported.
Posted
Number
95% Confidence Interval
percentage of subjects
Baseline (Day 1) and Weeks 24, 36 and 48
ID
Title
Description
OG000
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
OG001
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
OG002
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
Secondary
Percentage of Subjects Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Weeks 24, 36 and 48
The vision threatening complications in the study eye due to diabetic retinopathy were indicated by the presence of "Vitreous hemorrhage" or the presence of "Tractional retinal detachment" reported on the Ocular Examination - Dilated Ophthalmoscopy CRF (PDR events), and "Neovascularization for the Iris" answered as "Yes" or "Neovascularization for the Angle" answered as "Yes" per the Ocular Examination - Slit Lamp Biomicroscopy CRF (anterior segment neovascularization (ASNV) events).
The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
Posted
Number
95% Confidence Interval
percentage of subjects
Weeks 24, 36 and 48
ID
Title
Description
OG000
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
OG001
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
OG002
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
Secondary
Percentage of Subjects Who Developed Center Involved-Diabetic Macular Edema (CI-DME) at Weeks 24, 36 and 48
The CI-DME in the study eye occurred when a treatment emergent adverse event (TEAE) with a mapped preferred term of 'Cystoid macular oedema', 'Diabetic retinal oedema', or 'Macular oedema' occurred in the study eye, in combination with the temporally closest centrally read custom algorithm CST measurement being greater than or equal to 320 microns.
The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
Posted
Number
95% Confidence Interval
percentage of subjects
Weeks 24, 36 and 48
ID
Title
Description
OG000
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
OG001
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
OG002
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
Secondary
Time to Develop Any Neovascular Vision Threatening Complication (PDR/ASNV) at Weeks 24, 36 and 48
Time to develop any PDR/ASNV was computed as the date of the first development of PDR/ASNV in the study eye minus the date of study treatment administration plus 1 day, divided by 7 days per week.
The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham). Only subjects developed any PDR/ASNV at specific timepoint are analyzed.
Posted
Median
95% Confidence Interval
weeks
Weeks 24, 36 and 48
ID
Title
Description
OG000
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
OG001
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
OG002
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
Units
Counts
Secondary
Time to Develop CI-DME Through Weeks 24, 36 and 48
The occurrence of a CI-DME event in the study eye was identified via examination of centrally read custom algorithm CST data and adverse events.
The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham). Only subjects developed CI-DME event at specific timepoint are analyzed.
Posted
Median
95% Confidence Interval
weeks
Weeks 24, 36 and 48
ID
Title
Description
OG000
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
OG001
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
OG002
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
Units
Counts
Participants
Secondary
Percentage of Subjects Who Received Anti-Vascular Endothelial Growth Factor (VEGF) or Additional Standard of Care Intervention Due to Ocular Diabetic Complications at Weeks 24, 36 and 48
Percentage of subjects who received anti-VEGF or additional standard of care intervention due to ocular diabetic complications in the study eye are reported. Anti-VEGF use was identified in reported concomitant medication data.
The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
Posted
Number
95% Confidence Interval
percentage of subjects
Weeks 24, 36 and 48
ID
Title
Description
OG000
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
OG001
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
OG002
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
Units
Counts
Secondary
Percentage of Subjects Who Received PRP at Weeks 24, 36 and 48
Percentage of subjects who received PRP in the study eye, inclusive of subjects undergoing vitrectomy with endo-laser are reported.
The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
Posted
Number
95% Confidence Interval
percentage of subjects
Weeks 24, 36 and 48
ID
Title
Description
OG000
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
OG001
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
OG002
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
Units
Counts
Participants
Secondary
Area Under the Curve (AUC) for Change From Baseline in BCVA at Weeks 24, 36 and 48
The AUC for change from baseline in BCVA in the study eye were summarized. The AUC through each time point of interest was computed using the trapezoidal rule normalized to months, with a final unit of letters.
The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
Posted
Mean
Standard Deviation
letters
Weeks 24, 36 and 48
ID
Title
Description
OG000
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
OG001
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
OG002
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
Units
Counts
Participants
Secondary
Plasma Concentration of EYP-1901 and X-297 at Weeks 24, 36 and 48
Blood samples were collected at the specific visits for the Pharmacokinetic (PK) analysis of EYP-1901 and its main metabolite concentrations.
The PK analysis set included all subjects in the Safety set for whom at least 1 evaluable PK sample was available. Only subjects analysis at specific timepoints are reported.
Posted
Mean
Standard Deviation
mcg/mL
Weeks 24, 36 and 48
ID
Title
Description
OG000
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
OG001
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
Units
Counts
Participants
OG000
Secondary
Number of Subjects With Ocular and Non-Ocular TEAEs and Serious TEAEs up to Week 48
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational or marketed (medicinal) product and that does not necessarily have a causal relationship with the product. A serious AE is any AE that results in one of the following outcomes: death; life-threatening; requires in-patient hospitalization; results in a persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. The TEAEs are AEs that occur after the first dose of study treatment administration.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
Posted
Count of Participants
Participants
No
TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
ID
Title
Description
OG000
Sham Injection - Study Eye
Subjects received a single dose of sham IVT injection on Day 1.
OG001
Sham Injection - Non-study Eye
No study treatment administered in non-study eye.
OG002
Sham Injection - Non-ocular
Time Frame
TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
Description
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Sham Injection - Study Eye
Subjects received a single dose of sham IVT injection on Day 1.
0
26
1
26
7
26
EG001
Sham Injection - Non-study Eye
No study treatment administered in non-study eye.
0
26
1
26
5
26
EG002
Sham Injection - Non-ocular
Subjects received a single dose of sham IVT injection on Day 1.
1
26
2
26
9
26
EG003
EYP-1901 2060 mcg - Study Eye
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
0
26
1
26
8
26
EG004
EYP-1901 2060 mcg - Non-study Eye
No study treatment administered in non-study eye.
0
26
1
26
8
26
EG005
EYP-1901 2060 mcg - Non-ocular
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
1
26
7
26
14
26
EG006
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
0
25
0
25
8
25
EG007
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
0
25
0
25
5
25
EG008
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
0
25
1
25
7
25
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure congestive
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG0030 events0 affected26 at risk
EG0040 events0 affected26 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected25 at risk
EG0070 events0 affected25 at risk
EG0082 events1 affected25 at risk
Diabetic retinopathy
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Macular oedema
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Vitreous haemorrhage
Eye disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Death
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Endophthalmitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected26 at risk
EG003
Peritonsillitis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0021 events1 affected26 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0011 events1 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected26 at risk
EG0010 events0 affected26 at risk
EG0020 events0 affected26 at risk
EG003
Pancreatic carcinoma stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)