Overview

Safety Study of PF582 Versus Lucentis in Patients With Age Related Macular Degeneration

Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
The aim of this study is to test if PF582 (ranibizumab) is safe and similar to Lucentis (ranibizumab). Participants will have a screening visit to check for eligibility. Eligible participants will receive either PF582 or Lucentis, by injection into one eye on study Day 1, 28 and 56. Visits will be conducted on Day 2, 7, 14 80 and at 6 and 12 months. During the study participants will undergo the following procedures: height, weight and vital signs (blood pressure, pulse, temperature, breathing rate) measurement; medical and surgical history and concomitant medications; adverse event monitoring; physical examinations; eye tests (reading chart, measurement of retinal thickness [via pictures of the retina] and examination of the eye's blood vessels, via pictures taken following injection of a dye into the arm), blood collection and a urine pregnancy test, where applicable.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Pfenex, Inc
Treatments:
Ranibizumab