Status:
ACTIVE_NOT_RECRUITING
A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
Lead Sponsor:
EyeBiotech Ltd.
Conditions:
Diabetic Macular Edema (DME)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
EYE-RES-103 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 ma...
Detailed Description
EYE-RES-103 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 ma...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- Be male or female ≥18 years of age.
- Have type 1 or type 2 diabetes mellitus and a HbA1c of ≤12%.
- Have a decrease in vision in the study eye determined by the investigator to be primarily the result of DME.
- Exclusion Criteria:
- Be pregnant or breastfeeding
- History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
- Have any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy within 90 days of Screening
- Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
- If treatment-experienced for DME have a history of any of the following treatments within the noted time windows:
- Have had prior treatment with 8 mg aflibercept (EYLEA HD) or faricimab (VABYSMO) within 120 days prior to the Screening visit in the study eye
- Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept \[2 mg\], brolucizumab, pegaptanib sodium) in the study eye within 90 days of the Screening visit
Exclusion
Key Trial Info
Start Date :
April 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2028
Estimated Enrollment :
1054 Patients enrolled
Trial Details
Trial ID
NCT06957080
Start Date
April 16 2025
End Date
March 30 2028
Last Update
January 6 2026
Active Locations (164)
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1
Gilbert, Arizona
Gilbert, Arizona, United States, 85297
2
Phoenix, Arizona
Phoenix, Arizona, United States, 85020
3
Scottsdale, AZ
Scottsdale, Arizona, United States, 85255
4
Fayetteville, AR
Fayetteville, Arkansas, United States, 72703