Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD
NCT ID: NCT03479372
Last Updated: 2019-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
51 participants
INTERVENTIONAL
2018-04-26
2019-06-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PAN-90806 Eye Drops, dose 1
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
PAN-90806 Ophthalmic Suspension
PAN-90806 provided in single-use dropper bottles for topical ocular administration
PAN-90806 Eye Drops, dose 2
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
PAN-90806 Ophthalmic Suspension
PAN-90806 provided in single-use dropper bottles for topical ocular administration
PAN-90806 Eye Drops, dose 3
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
PAN-90806 Ophthalmic Suspension
PAN-90806 provided in single-use dropper bottles for topical ocular administration
Interventions
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PAN-90806 Ophthalmic Suspension
PAN-90806 provided in single-use dropper bottles for topical ocular administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
ALL
No
Sponsors
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PanOptica, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Wax, MD
Role: STUDY_DIRECTOR
PanOptica, Inc.
Locations
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Colorado Retina Associates
Golden, Colorado, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Retinal Consultants of Nevada
Henderson, Nevada, United States
Retinal Consultants of Nevada
Las Vegas, Nevada, United States
Retina Center of New Jersey
Bloomfield, New Jersey, United States
Retina Center of New Jersey
Teaneck, New Jersey, United States
Vision Research Center
Albuquerque, New Mexico, United States
Duke University
Durham, North Carolina, United States
Fakultní nemocnice Královské Vinohrady
Prague, , Czechia
Axon Clinical
Prague, , Czechia
Semmelweis University
Budapest, , Hungary
University of Debrecen
Debrecen, , Hungary
P. Stradina Clinical University hospital
Riga, , Latvia
Barnet Hospital
Barnet, Hertfordshire, United Kingdom
New Cross Hospital
Wolverhampton, West Midlands, United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Moorefields Eye Hospital
London, , United Kingdom
Manchester Royal Eye Hospital
Manchester, , United Kingdom
Countries
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Other Identifiers
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PAN-01-102
Identifier Type: -
Identifier Source: org_study_id
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