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.
960Patients around the world