Study of Topical Ocular PAN-90806 in PDR
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular, Diabetes |
| Therapuetic Areas: | Endocrinology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2015 |
| End Date: | July 2016 |
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.
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
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2
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