Study of Topical Ocular PAN-90806 in PDR

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PanOptica, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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