Study of Topical Ocular PAN-90806 in PDR

PanOptica

Status and phase

Completed

Phase 1

Conditions

Diabetic Retinopathy

Treatments

Drug: PAN-90806 Ophthalmic Solution

Study type

Interventional

Funder types

Industry

Identifiers

PAN-01-201

Details and patient eligibility

About

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

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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