Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:4/21/2016
Start Date:February 2014
End Date:June 2016

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A Phase I Open-Label, Multi-Center Trial With Randomization to Dose to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Neovascular Age-Related Macular Degeneration (AMD)

The objective of this study is to assess the safety and tolerability of topical ocular
PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with
neovascular Age-Related Macular Degeneration (AMD).


Inclusion Criteria:

- Diagnosis in the study eye of active, pathologic, newly diagnosed and previously
untreated, subfoveal choroidal neovascular (CNV) lesions secondary to neovascular AMD

- Aged 50 years or older

- Demonstrate the ability, or have a family member who is willing and able, to instill
topical ocular drops in the study eye

Exclusion Criteria:

- No prior ocular or systemic treatment or surgery for neovascular AMD in the study eye

- History of or current clinical evidence in the study eye of:

- aphakia

- diabetic macular edema

- any ocular inflammation or infections

- pathological myopia

- retinal detachment

- advanced glaucoma

- significant media opacity, including cataract

- History or evidence of the following surgeries in the study eye:

- penetrating keratoplasty or vitrectomy;

- corneal transplant;

- corneal or intraocular surgery within 3 months of Screening

- Uncontrolled hypertension despite use of antihypertensive medications

- 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
22
sites
Portsmouth, New Hampshire 03801
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Portsmouth, NH
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Abilene, TX
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Ashland, OR
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Austin, TX
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Bloomfield, NJ
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Boston, MA
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Charlotte, North Carolina 28207
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Charlotte, NC
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Colorado Springs, Colorado 80910
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Colorado Springs, CO
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Durham, NC
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Harlingen, TX
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Madison, WI
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McAllen, TX
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Nashville, TN
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Philadelphia, PA
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Rapid City, SD
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San Antonio, TX
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Shawnee Mission, KS
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Statesville, North Carolina 28677
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Statesville, NC
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West Columbia, South Carolina 29169
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West Columbia, SC
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Wichita, KS
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Willow Park, TX
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Winter Haven, FL
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