Age Related Macular Degeneration (AMD) Clinical Trial
Official title:
A Pilot Phase 1/2, Double Blind, Parallel Group, Controlled Study of the Safety, Tolerability and Preliminary Efficacy Evaluation of Intravitreally Administered Pfenex Ranibizumab Biosimilar Versus Lucentis for the Treatment of Neovascular AMD
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.
To evaluate the safety and tolerability of PF582, compared to that of Lucentis (registered
trademark) in patients with neovascular AMD. This will be done by assessment of vital signs,
physical examination, laboratory blood tests and adverse events. Possible adverse events
include: eye irritation/discomfort, redness/itching eye, eye dryness, abnormal sensation in
eye; lens clouding; pain/irritation at injection site; increased tear production;
'floaters'; sore throat, nasal congestion, headache, joint pain, flu, fatigue,
breathlessness, dizziness, pale skin, anxiety, cough, nausea and allergic reactions.
Because PF582 is very similar to Lucentis it is expected to have similar adverse effects.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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