An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Geographic Atrophy

In brief

This is a multicenter, open-label extension study of safety and tolerability of lampalizumab administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week treatment in Study GX29455 (NCT02288559).

Key facts

Study ID

NCT01602120

Run by

Genentech, Inc.

People needed

159

Starts

2012-05-29

Expected to finish

2018-02-09

Last updated by the study team

2019-09-11

Who can join

Age: 60 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For CFD4870g participants: Previous enrollment and completion (Month 18 visit) of Study CFD4870g without early treatment discontinuation (lampalizumab or sham)
• For GX29455 participants: Previous enrollment and completion (Week 24 visit) of Study GX29455 without early treatment discontinuation (lampalizumab or sham)
• Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging

You may not qualify if…

• Early treatment and/or study discontinuation prior to completion of study CFD4870g (GX01456) and GX29455
• Vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) in the study eye
• Subfoveal focal laser photocoagulation in the study eye
• Treatment with Visodyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
• Intravitreally (ITV) drug delivery (e.g., ITV corticosteroid injection, anti-angiogenic drugs, anticomplement drugs, or device implantation) in the study eye. Lampalizumab in study eye and ranibizumab in either eye are permitted
• Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications

Where it is running

• Retina Centers P.C. — Tucson, Arizona, United States
• Retina-Vitreous Assoc Med Grp — Beverly Hills, California, 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
• W Coast Retina Med Group Inc — San Francisco, California, United States
• West Coast Retina — San Francisco, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Retina Macula Institute — Torrance, California, United States
• Colorado Retina Associates, PC — Golden, Colorado, United States
• Retina Group of Florida — Boca Raton, 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
• Ctr for Retina & Macular Dis — Winter Haven, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Wolfe Eye Clinic — West Des Moines, Iowa, United States
• Elman Retina Group — Baltimore, Maryland, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, 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

Full record on ClinicalTrials.gov

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