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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PanOptica, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions; Ranibizumab

Criteria

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