Safety Study of iSONEP (Sonepcizumab/LT1009) to Treat Neovascular Age-related Macular Degeneration

Inclusion Criteria:

• 50 years and older
• BCVA ETDRS letter score in study eye between 20-57 letters using ETDRS refraction (Snellen of 20/70-20/400)
• Any CNV secondary to AMD in study eye, classic, minimally classic or occult with leakage on fluorescein angiography and intraretinal or subretinal fluid on OCT
• Visual acuity in fellow eye must be 20/800 or better at 4 meters
• Able to read, understand and sign the consent form before entering into study

Exclusion Criteria:

• Ocular disease other than CNV that could compromise vision in study eye
• Systemic immunosuppressive medication/therapy (e.g., chemotherapy, steroids)
• Uncontrolled hypertension and/or arrhythmias
• QT/QTc interval measurement >450 msec
• Cancer within the last 2 years except superficial basal or squamous cell skin cancer or cervical carcinoma in situ
• Have angioid streaks, presumed ocular histoplasmosis syndrome, myopia (>8 diopters) or CNV secondary to other causes than AMD
• Any additional ocular diseases which have irreversibly compromised visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema and severe non-proliferative diabetic retinopathy
• Any intraocular or general surgery, including cataract surgery, within 2 months of Day 1
• History of uveitis in either eye
• Any ocular or periocular infection within 4 weeks prior to Day 1
• Active ocular inflammation grade trace and above
• Cup to disc ratio >0.8, IOP >21 mmHg in glaucoma subjects treated with more than 2 ocular hypotensive agents
• Previous pars plana vitrectomy or trabeculectomy in study eye
• History of anterior vitrectomy
• Inability to obtain photographs, FA or OCT to document CNV, e.g. due to media opacity, allergy to fluorescein dye or lack of venous access
• Aphakia
• Previous intravitreal Macugen, Avastin or Lucentis (injection or drug device implantation) in study eye within 6 weeks or triamcinolone within 6 months
• Receiving or requiring chronic concomitant therapy with systemic anti-angiogenic treatments p.o., parenteral (excluding inhaled steroids) (>5 mg) or topical corticosteroids in the study eye
• PDT within 12 weeks prior to Day 1
• Subjects taking systemic anticoagulants such as warfarin
• Investigational agents or devices within 6 weeks prior to Day 1
• Females who are pregnant or nursing and women of child bearing potential who are not using adequate contraceptive precautions