Diabetic Macular Edema (DME)
Conditions
Brief summary
The primary endpoint (or outcome) of this study is to find out whether EYP-1901 can produce the same vision benefits as aflibercept over 56 weeks.
Detailed description
The secondary endpoints (or outcomes) of the study are to find out: • How often injections are needed over the 56 weeks of treatment, • Changes in the thickness of the retina (light-sensitive membrane at the back of the eye) from the first treatment over time, • The percentage of participants who maintain, gain, or lose a certain number of letters on an eye chart over time, • The percentage of participants who need additional aflibercept injections up to 88 weeks, • The total number of additional aflibercept injections needed by Week 88, • The percentage of participants whose DME improves over time and also how quickly DME improves over time
Interventions
Sponsors
Eyepoint Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint (or outcome) of this study is to find out whether EYP-1901 can produce the same vision benefits as aflibercept over 56 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints (or outcomes) of the study are to find out: • How often injections are needed over the 56 weeks of treatment, • Changes in the thickness of the retina (light-sensitive membrane at the back of the eye) from the first treatment over time, • The percentage of participants who maintain, gain, or lose a certain number of letters on an eye chart over time, • The percentage of participants who need additional aflibercept injections up to 88 weeks, • The total number of additional aflibercept injections needed by Week 88, • The percentage of participants whose DME improves over time and also how quickly DME improves over time | — |
Outcome results
None listed