None listed
Conditions
Brief 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.
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.
Sponsors
Pfenex Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- 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 criteria
- 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
Outcome results
None listed