a study to evaluate the efficacy and safety of tarcocimab tedromer compared with sham treatment in participants with diabetic retinopathy (dr)

Conditions: Diabetic Retinopathy

Summary: this study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with dr.

this is a prospective, randomized, double-masked, two-arm, multi-center phase 3 study to demonstrate that tarcocimab 5 mg is superior to sham treatment, with respect to the proportion of eyes improving from baseline at week 48 in participants with dr.

Eligibility criteria:
inclusion criteria: * signed informed consent prior to participation in the study. * type 1 or 2 diabetes mellitus and hba1c of ≤12%. * dr in the study eye (drss as determined by the reading center based on color fundus photographs), who have not previously received intravitreal medications for dr or dme, and in whom pan-retinal photocoagulation (prp) can be safely deferred for at least 6 months per the investigator. * cst ≤320 microns and a bcva etdrs letter score in the study eye of ≥69 letters (approximate snellen equivalent of 20/40 or better) in the study eye at screening and confirmed at day 1; or * cst \>320 and ≤350 microns and a bcva etdrs letter score in the study eye of ≥79 letters (approximate snellen equivalent of 20/25 or better) in the study eye at screening and confirmed at day 1. exclusion criteria: * prior prp in the study eye. * current anterior segment neovascularization (asnv), vitreous hemorrhage, or tractional retinal detachment in the study eye. * prior intravitreal anti-vegf treatment in the study eye for dr or dme within the last twelve (12) months prior to day 1. * prior intravitreal or periocular steroid in the study eye for dr or dme within the last twelve (12) months prior to day 1. * prior use of an investigational intravitreal treatment for dr or dme in the study eye. * history of vitreoretinal surgery in the study eye. * history of uveitis in either eye. * cataract in the study eye that in the judgment of the investigator is expected to require surgical extraction within 12 months of screening. * significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, oct, or fp. * any history or evidence of a concurrent ocular condition present in the study eye, that in the opinion of the investigator could require either medical or surgical intervention or alter visual acuity during the study. * active or suspected ocular or periocular infection or inflammation. * women who are pregnant or lactating or intending to become pregnant during the study. * history of a medical condition that, in the judgment of the investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product. * recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event. * uncontrolled blood pressure defined as a systolic value ≥ 180 mmhg or diastolic value ≥ 100 mmhg while at rest. * other protocol-specified exclusion criteria may apply.

Keywords: diabetic retinopathy npdr ksi-301 vegf anti-vegf vascular endothelial growth factor antibody biopolymer conjugate retinal degeneration retinal diseases eye diseases retinopathy vision disorders kodiak tarcocimab tedromer tarcocimab diabetic eye disease