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Pan Optica


Title A Phase 1, 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)
Therapeutic Area Macular Degeneration, Ophthalmology
Principal Investigator Andre Witkin, MD
Min Age 50 Years
Gender both
Contact Millie Commodore
617-636-1051
More Information http://clinicaltrials.gov/ct2/show/NCT02022540

Overview

The purpose of this study is to assess the safety and tolerability of the investigational eye drop solution, PAN-90806. The biological response to the eye drops will also be assessed to see if the drug helps slow the progression of neovascular age-related macular degeneration.  Participants (age 50 years and older) enrolled in the study will be randomized into one of three study arms (1 mg/ml BID, 2 mg/ml BID, 4 mg/ml QD).

Study Details

Inclusion Criteria

  • Active, and previously untreated, subfoveal CNV lesions secondary to neovascular macular degeneration
  • Best-corrected visual acuity between 20/63 to 20/160 in the study eye
  • Patient, or patient’s family member, must be willing and able to instill topical ocular drops in the study eye up to two times per day

Exclusion Criteria

  • Additional eye disease in the study eye that would compromise best-corrected visual acuity
  • Best-corrected visual acuity in the fellow eye of worse than 20/320
  • Any prior ocular or systemic treatment or surgery for neovascular macular degneration in the study eye, with the exception of dietary supplements or vitamins

Study Requirements

After participants pass a screening visit, they will be asked to instill investigational eye drops for 8 weeks and come in for a total of 7 visits.

A total of 4 fluorescein angiograms and 4 blood collections will be required for the study