Assessment of Safety, Tolerability and Pharmacokinetics of Intravitreal Pegcetacoplan (APL-2) for Patients With Wet AMD

Inclusion criteria

• Male or Female
• Age ≥ 50 years
• The presence of an active choroidal neovascular lesion secondary to AMD
• On treatment with anti-VEGF therapy (Lucentis®, Eylea® or Avastin®)
• Must have received at least 3 anti-VEGF treatments over the 26-week period prior to screening (Screening Visit)
• Evidence that the macular fluid has responded to anti-VEGF in the past based on OCT in the opinion of PI
• At screening, evidence of subretinal fluid and retinal cystic changes
• Must have received anti-VEGF treatment within 10 days prior to pegcetacoplan treatment (anti-VEGF can be administered on the same day of the screening visit after the screening procedures have been completed)
• OCTs of sufficient quality to allow for the assessment of the central macular fluid can be obtained
• Female subjects must be:

• Women of non-child-bearing potential (WONCBP), Or
• Women of child-bearing potential (WOCBP) with a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study
• Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study
• Willing and able to give informed consent

Exclusion criteria

• Choroidal neovascularization associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc
• Decreased vision due to retinal disease not attributable to choroidal neovascularization, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (e.g., as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy
• Additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy
• Decreased vision due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina
• Cataract surgery within three months of enrollment
• Presence of any hemorrhage
• History of treatment for CNV:

• Previous PDT treatment within 30 days prior to enrollment in the study
• Previous extrafoveal or juxtafoveal thermal laser photocoagulation within 30 days prior to enrollment in the study
• Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization
• Medical problems that make consistent follow-up over the treatment period unlikely (e.g. stroke, severe MI, end stage malignancy), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections
• Hypersensitivity to fluorescein