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

Completed · Phase 1

Conditions studied: Age-Related Macular Degeneration (AMD)

In brief

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).

Key facts

Study ID

NCT02022540

Run by

PanOptica, Inc.

People needed

50

Starts

2014-02-01

Expected to finish

2016-05-01

Last updated by the study team

2016-09-28

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…

• 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

Where it is running

• Study site — Colorado Springs, Colorado, United States
• Study site — Winter Haven, Florida, United States
• Study site — Shawnee Mission, Kansas, United States
• Study site — Wichita, Kansas, United States
• Study site — Boston, Massachusetts, United States
• Study site — Portsmouth, New Hampshire, United States
• Study site — Bloomfield, New Jersey, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Statesville, North Carolina, United States
• Study site — Ashland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — West Columbia, South Carolina, United States
• Study site — Rapid City, South Dakota, United States
• Study site — Nashville, Tennessee, United States
• Study site — Abilene, Texas, United States
• Study site — Austin, Texas, United States
• Study site — Harlingen, Texas, United States
• Study site — McAllen, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Willow Park, Texas, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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