Title
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 Biosimilar Versus Lucentis for the Treatment of Neovascular AMD
Phase
Phase 1/Phase 2Lead Sponsor
Pfenex, IncStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Age Related Macular Degeneration (AMD)Intervention/Treatment
ranibizumab ...Study Participants
25The 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.
Single-use 2 mL vial designed to deliver 0.05 mL of 10 mg/mL ranibizumab solution. Excipients: Alpha, alpha-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections Route of Administration: Intra-vitreal
Single-use 2 mL vial designed to deliver 0.05 mL of 10 mg/mL ranibizumab solution. Excipients: Alpha, alpha-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections Route of Administration: Intra-vitreal
Inclusion Criteria: Age ≥50 years Presence in the study eye (one eye per patient) of previously untreated active subfoveal CNV due to AMD, with presence of leakage, as seen on FA, and of fluid, as seen on spectral-domain OCT, located either within or below the retina, or below the retinal pigment epithelium Visual acuity between 20/25 and 20/320 being measured using the Early treatment diabetic retinopathy study (ETDRS) protocol1 (chart at 4 meters) before pupil dilation. Neovascularization, fluid, or haemorrhage under the fovea. Fibrosis < 50% of total lesion area At least 1 drusen (>63μm) in either eye or late AMD in fellow eye. Female subjects must be of non-childbearing potential, meeting at least one of the following criteria: Amenorrheal for 12 months (Menopause confirmed by FSH and LH levels as defined by the established reference ranges), or taking oral contraception for at least 3 months, or surgically sterile for at least the past 3 months, or Receiving a stable dose of implanted or injectable contraceptive for at least 3 months Exclusion Criteria: Previous treatment for CNV in study eye, including antivascular endothelial growth factor(VEGF) medication Other progressive retinal disease in the study eye, or the non-study eye, likely to compromise Visual Acuity assessment. Contraindications to injections with Lucentis® Sub-retineal Haemorrhage > 50% of lesion Fibrosis or retrofoveolar atrophy History of retrofoveolar laser photocoagulation 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
