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Intravitreal Insert
EYP-1901 for Diabetic Retinopathy
Phase 2
Recruiting
Research Sponsored by EyePoint Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Study eye with moderately severe to severe NPDR (based on the DRSS levels 47 or 53)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24, week 36, week 48
Awards & highlights
Study Summary
This trial studied the safety and effectiveness of a medication delivered directly into the eye to treat a condition, compared to a dummy treatment.
Who is the study for?
This trial is for people with a type of eye condition called Nonproliferative Diabetic Retinopathy (NPDR) who can see fairly well (about 20/40 vision or better). They must have their diabetes under some control, with an A1c of 12% or less. It's not for those who've had certain eye treatments in the past year or have swelling in the center part of the retina.Check my eligibility
What is being tested?
The study is testing EYP-1901, which is a new treatment given as an injection inside the eye. Participants will be randomly assigned to receive either one of two doses of EYP-1901 or a pretend treatment without any active drug (sham). The researchers are keeping track of how well it works and its safety.See study design
What are the potential side effects?
While specific side effects aren't listed here, intravitreal injections like EYP-1901 could potentially cause eye irritation, increased pressure inside the eye, bleeding, infection, and possibly temporary visual disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye condition is classified as moderately severe to severe non-proliferative diabetic retinopathy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24, week 36, week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24, week 36, week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of subjects improving ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score each EYP-1901 dose level versus the sham IVT injection group.
Secondary outcome measures
Percentage of subjects improving ≥2 steps in the DRSS score in each dose level vs. sham
Percentage of subjects who developed a vision-threatening complication due to diabetic retinopathy
Rates of ocular (study eye and fellow eye) and non-ocular Treatment-Emergent Adverse Events
Side effects data
From 2020 Phase 4 trial • 26 Patients • NCT030222924%
Retinal detachment
4%
Myelodysplastic syndrome
4%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IAI Treatment
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: EYP-1901 3090 ugExperimental Treatment1 Intervention
EYP-1901 3090 ug; single injection
Group II: EYP-1901 2060 ugExperimental Treatment1 Intervention
EYP-1901 2060 ug; single injection
Group III: Sham IVTPlacebo Group1 Intervention
Sham IVT; single injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EYP-1901
2021
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
EyePoint Pharmaceuticals, Inc.Lead Sponsor
16 Previous Clinical Trials
1,826 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
167 Patients Enrolled for Diabetic Retinopathy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your vision in the study eye is about 20/40 or better.I have not had specific laser treatments in my study eye in the last year.My study eye has diabetic macular edema with a thickness over 320 microns.My eye condition is classified as moderately severe to severe non-proliferative diabetic retinopathy.Your hemoglobin A1c level should be 12% or lower.
Research Study Groups:
This trial has the following groups:- Group 1: EYP-1901 3090 ug
- Group 2: Sham IVT
- Group 3: EYP-1901 2060 ug
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment of participants ongoing for this clinical experiment?
"Clinicaltrials.gov states that this study is still taking applicants, the initial post date being August 31st 2022 and its most recent edit being February 13th 2023."
Answered by AI
To what extent does EYP-1901 2060 ug pose a threat to users?
"Our team at Power scores EYP-1901 2060 ug's safety as a 2 since, while there is evidence of its security in Phase 2 trials, efficacy data has yet to be collected."
Answered by AI
How many participants are currently receiving treatment as part of this trial?
"Affirmative, the information provided by clinicaltrials.gov suggests that this experiment still needs participants. It was posted on August 31st 2022 and amended lastly on February 13th 2023. At present, 105 patients must be recruited from 26 various medical establishments."
Answered by AI
How many facilities offer access to this clinical trial?
"The present clinical trial is recruiting participants from 26 different sites. These include Huntington Beach, Oxnard and Palm Desert, among other places. To make the process easier on you, it may be beneficial to choose a location near your residence in order to reduce travel demands."
Answered by AI
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