A Single Ascending Dose Cohort Study of AG-73305 in DME Patients

Inclusion criteria

• Male or female, 18 years of age or older at the screening visit
• Prior diagnosis of diabetes mellitus (Type 1 or Type 2) as defined by World Health Organization or American Diabetes Association
• Presence of center-involving DME in the study eye with CST ≥ 325 μm
• Visual acuity loss in the study eye attributed to DME with screening and baseline ETDRS BCVA letter score of 20 to 55 (20/400 to 20/80 Snellen equivalent) in the sentinel patients and 35 to 70 (20/200 to 20/40 Snellen equivalent) in the non-sentinel patients
• Cohort 1: Previously treated with an anti-VEGF in the study eye; Cohorts 2, 3, and 4: Previously treated or treatment-naïve to the study eye

Exclusion criteria

• Uncontrolled diabetes mellitus, defined as hemoglobin A1c > 12.0% at Screening
• Uncontrolled hypertension with systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg at Screening or Baseline
• Chronic renal disease
• Any active infection in either eye
• Any anti-vascular endothelial growth factor (VEGF) treatment in the study eye within 6 to 8 weeks prior to Baseline
• Use of Ozurdex (dexamethasone) within 6 months prior to Baseline or any use of Iluvien (fluocinolone acetonide) in the study eye
• Uncontrolled intraocular pressure (IOP), defined as an IOP > 25 mmHg, despite anti-glaucoma medications in the study eye at the time of screening or controlled glaucoma that requires management with > 2 topical hypotensive medications
• Any anti-integrin therapy (e.g., Xiidra) within 60 days before baseline in the study eye