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

Completed · Phase 1/Phase 2

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT03479372

Run by

PanOptica, Inc.

People needed

51

Starts

2018-04-26

Expected to finish

2019-06-27

Last updated by the study team

2019-07-09

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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