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

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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
We found this trial at
2
sites
McAllen, Texas 78503
797
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McAllen, TX
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Harlingen, Texas 78550
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Harlingen, TX
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