A Phase I Single Ascending Dose Study of the Intravitreal Plasma Kallikrein Inhibitor KVD001 in Subjects With DME

Inclusion Criteria

• •1. Male or female adult subjects 18 years of age and older
• •2. Confirmed diagnosis of Type I or Type II diabetes mellitus
• •3. Best corrected visual acuity, using Early Treatment Diabetic Retinopathy Study (ETDRS) electronic visual acuity (EVA) testing, of between 20/40 and 20/400 (Snellen equivalent) in the study eye
• •4. Fellow eye acuity 20/80 or better measured as above with no expectation of requirement for anti-VEGF treatment in fellow eye within 2 months of study drug administration
• •5. Presence of central involved DME in the study eye defined as Optical Coherence Tomography (OCT) Central Subfold Thickness (CST) ≥305 µm in women and ≥320 µm in men in the study eye
• •6. Subjects who fulfil one of the following criteria:
• •1. Subjects who have not previously received an anti-VEGF treatment and who, in the view of the Investigator, can have initiation of anti-VEGF treatment in the study eye deferred for at least 2 months following the date of anticipated study drug administration
• •2. Subjects who are receiving regular anti-VEGF intravitreal injections who:
• •* Have received at least 3 intravitreal injections of an anti-VEGF treatment within the last 5 months (study drug administration will be at least 6 weeks after the most recent intravitreal administration of anti-VEGF) and
• •* In the view of the Investigator, can have continuation of anti-VEGF treatment in the study eye deferred for at least 2 months following the date of anticipated study drug administration
• •3. Subjects who have received anti-VEGF in the past (\>3 months prior to study inclusion) but are not actively receiving treatment and who in the view of the Investigator, can have resumption of anti-VEGF or alternative treatment in the study eye deferred for at least 2 months following anticipated study drug administration
• •7. Subjects, who in the view of the Investigator, are not expected to require panretinal laser photocoagulation or intravitreal steroids or intraocular surgery in the study eye for at least 2 months following anticipated study drug administration
• •8. No prior treatment with panretinal photocoagulation or intravitreal steroid in the study eye within the previous 3 months
• •9. No prior treatment with systemic corticosteroids or systemic anti-VEGF therapy within the previous 3 months
• •10. Study participant voluntarily agrees to participate in this study and signs the Institutional Review Board (IRB) approved informed consent prior to performing any procedure