A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy

A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Exposure-Response Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy

This multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.

Inclusion Criteria:

• Complement Factor I (CFI) profile biomarker-positive result
• Women of child bearing potential and men should remain abstinent or use contraceptive methods

Exclusion Criteria:

• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
• Previous subfoveal focal laser photocoagulation in study eye
• Laser photocoagulation in the study eye
• Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in study eye
• Previous intravitreal drug administration in study eye. A single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to screening is permitted
• Previous cell-based intraocular treatment in study eye
• Intraocular surgery in study eye
• Uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye
• History of corneal transplant in study eye
• GA in either eye due to causes other than AMD
• Proliferative diabetic retinopathy in either eye
• Active or history of neovascular (wet) AMD in either eye
• History of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease
• Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis
• Previous systemic treatment with complement inhibitor and with inhibitors/modulators of visual cycle
• Previous expression vector mediated intraocular treatments
• Uncontrolled blood pressure and atrial fibrillation
• Medical conditions associated with clinically significant risk for bleeding-
• Predisposition or history of increased risk for infection
• Active malignancy within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a Gleason score of less than or equal to 6, and a stable prostate-specific antigen for greater than or equal to (>/=) 12 months
• History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of lampalizumab injection
• Women of child bearing potential must have a negative serum pregnancy test within 28 days prior to initiation of study treatment
• Previous participation in other studies of investigational drugs