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A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME) In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm. Approximately 960 participants will be entered in the study.
Study details:
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME). Approximately 960 participants will be entered in the study. Participants will be randomized 1:1:1 to receive low dose EYE103, high dose EYE103, or 0.
5 mg ranibizumab, administered via intravitreal injection. In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm.
Throughout the 2-year study, subjects will be evaluated every 4 weeks, including measurement of ETDRS BCVA, examination by slit-lamp biomicroscopy, fundoscopy, and SD-OCT. Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-08-14
Primary completion: 2027-12-31
Study completion finish: 2027-12-31
Study type
TREATMENT
Phase
PHASE2
PHASE3
Trial ID
NCT06571045
Intervention or treatment
DRUG: Ranibizumab
DRUG: EYE103
Conditions
- • Diabetic Macular Edema (DME)
Find a site
Closest Location:
Sydney Retina Clinic
Research sites nearby
Select from list below to view details:
Sydney Retina Clinic
Sydney, New South Wales, Australia
Sydney, Australia
Sydney, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: EYE103 Low Dose Treatment Arm
| DRUG: EYE103
|
EXPERIMENTAL: EYE103 High Dose Treatment Arm
| DRUG: EYE103
|
ACTIVE_COMPARATOR: Ranibizumab Treatment Arm
| DRUG: Ranibizumab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart | Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart | 52 Weeks |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Changes in structural and visual outcomes | Changes in structural and visual outcomes | Duration of the study, through Week 104 |
Frequently Asked Questions
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