Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD



Status:Enrolling by invitation
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:2/27/2019
Start Date:April 26, 2018
End Date:June 15, 2019

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A Randomized, Double Masked, Uncontrolled , Multicenter Phase I/II Study to Evaluate Safety and Tolerability of PAN-90806 Eye Drops, Suspension in Treatment-Naïve Participants With Neovascular Age-Related Macular Degeneration (AMD)

Double-masked, uncontrolled, multi-center, study in which participants will be randomized to
one of 3 doses of topical ocular PAN 90806 administered once daily for 12 weeks.

Patients with newly diagnosed, active, pathologic CNV associated with neovascular AMD will be
screened for inclusion into the study after providing written informed consent. Participants
who are eligible for the study will be centrally randomized at Day 1 to one of three doses of
PAN-90806 Eye Drops. Participants will be instructed to apply one drop of PAN-90806 to the
ocular surface of the identified study eye once daily for twelve (12) weeks.

Participants will return for follow-up visits at Week 2, Week 4, Week 8, Week 12, 1 week
after stopping PAN-90806 treatment and 1 month after stopping PAN-90806 treatment.

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:

- Prior ocular or systemic treatment or surgery for neovascular AMD in the study eye

- Prior use within the last 3 months or a high possibility of requiring treatment with
anti-VEGF therapy in the fellow eye during the study

- Significant retinal serous pigment epithelial detachment (PED), atrophy, or
fibrosis/scar involving the fovea

- 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, and/or 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

- Women of child-bearing potential who are not using a highly effective form of birth
control

- 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
15
sites
Bloomfield, New Jersey 07003
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Albuquerque, New Mexico 87109
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Austin, Texas 78705
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Beechwood, Ohio 44122
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Fort Myers, Florida 33912
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Fort Myers, FL
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Golden, Colorado 80401
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Golden, CO
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Hagerstown, Maryland 21740
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Henderson, Nevada 89052
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Hradec Králové, 50005
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Indianapolis, Indiana 46290
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Indianapolis, IN
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Las Vegas, Nevada 89144
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Nashville, Tennessee 37203
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Pensacola, Florida 32503
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Teaneck, New Jersey 07666
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Teaneck, NJ
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