Study of Topical Ocular PAN-90806 in PDR

A Phase 1 Open-Label, Single-Center Study to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Proliferative Diabetic Retinopathy (PDR)

The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with proliferative diabetic retinopathy.

Inclusion Criteria:

• Aged 18 years or older with type 1 or type 2 diabetes
• Proliferative diabetic retinopathy (PDR) in study eye retina with or without diabetic macular edema (DME) involving the center of the macula
• Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye

Exclusion Criteria:

• Current or recent use (within the last 3 months) of anti-vascular endothelial growth factors (anti-VEGF) in either eye;
• Uncontrolled hypertension despite use of antihypertensive medications
• Unwillingness to refrain from wearing contact lenses for the duration of the study.
• Participation in any investigational drug or device study, systemic or ocular, within past 3 months
• Women who are pregnant or nursing
• Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation