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

• Status: Completed
• Trial end date: 2017-06-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Immunoglobulin Fab Fragments

Criteria

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