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

A Phase I Open-Label, Multi-Center Trial With Randomization to Dose to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Neovascular Age-Related Macular Degeneration (AMD)

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).

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