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

Completed · Phase 2 · Has a placebo group

Conditions studied: Geographic Atrophy

In brief

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.

Key facts

Study ID

NCT02288559

Run by

Genentech, Inc.

People needed

96

Starts

2015-03-30

Expected to finish

2017-06-02

Last updated by the study team

2019-09-25

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Barnet Dulaney Perkins Eye Center — Mesa, Arizona, United States
• University of Arizona; Banner University Medical, Department of Opthalmology — Tucson, Arizona, United States
• Northwest Arkansas Retina Associates — Springdale, Arkansas, United States
• Retinal Diagnostic Center — Campbell, California, United States
• The Retina Partners — Encino, California, United States
• Loma Linda University — Loma Linda, California, United States
• San Diego Retina Associates — Oceanside, California, United States
• West Coast Retina Medical Group — San Francisco, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Colorado Retina Associates, PC — Golden, Colorado, United States
• Florida Eye Microsurgical Inst — Boynton Beach, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Retina Care Specialists — Palm Beach Gardens, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Wolfe Eye Clinic — West Des Moines, Iowa, United States
• Elman Retina Group — Baltimore, Maryland, United States
• Vitreoretinal Surgery — Edina, Minnesota, United States
• The Retina Institute — St Louis, Missouri, United States
• Sierra Eye Associates — Reno, Nevada, United States
• Eye Associates of New Mexico — Albuquerque, New Mexico, United States
• Western Carolina Retinal Associate PA — Asheville, North Carolina, United States
• Char Eye Ear &Throat Assoc — Charlotte, North Carolina, United States
• Cincinnati Eye Institute — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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