Safety study of PF582 versus Lucentis in patients with age related macular degeneration
A Pilot Phase 1/2, Double Blind, Parallel Group, Controlled Study of the Safety, Tolerability and preliminary Efficacy evaluation of intravitreally administered Pfenex ranibizumab (PF582) biosimilar versus Lucentis (registered trademark) for the treatment of neovascular age related macular degeneration (AMD)
Pfenex Inc.
25 participants
Jan 16, 2014
Interventional
Conditions
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.
Eligibility
Inclusion Criteria7
- Presence in the study eye of previously untreated active
- neovascularization due to AMD
- Visual acuity between 20/25 and 20/320
- Neovascularization, fluid, or haemorrhage under the fovea
- Fibrosis less than 50% of total lesion area
- At least 1 drusen in either eye or late AMD in fellow eye
- Female participants must be of non-childbearing potential
Exclusion Criteria12
- Previous treatment for AMD in study eye
- Other progressive retinal disease in the study eye, or the non-study eye, likely to compromise Visual Acuity assessment.
- Contraindications to injections with Lucentis
- Previous Lucentis treatment
- Any other treatment (photocoagulation, phototherapy, radiotherapy, surgery, thermotherapy) in the last 3 months
- Aphaky, vitrectomy
- Active or suspected ocular or periocular infection
- Active intraocular inflammation
- Active systemic infection
- History of stroke or congestive heart failure
- Any other clinical significant illness or abnormalities that would compromise the safety of the participant
- Inability to comply with study or follow up procedures
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Interventions
0.05mL of Pfenex ranibizumab (PF582) biosimilar or Lucentis (registered trademark) ranibizumab administered intravitreally (injection in the eye) at Days 1, 28, and 56.
Locations(1)
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ACTRN12613001303730