Last updated 45 days ago

A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

960 patients around the world
Available in Puerto Rico, Colombia, United States
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 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.
EyeBiotech Ltd.
960Patients around the world

This study is for people with

Diabetic retinopathy
Diabetic macular edema

Requirements for the patient

From 18 Years
All Gender

Medical requirements

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.
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.
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