An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy
- Registration Number
- NCT01602120
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 159
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CFD4870g Lampalizumab Lampalizumab Participants will receive lampalizumab 10 mg, ITV, Q4W or Q8W in accordance with their previously assigned treatment frequency assignment in Study NCT01229215 (CFD4870g) followed by Q4W administration for the remainder of the extension study up to approximately 96 months. GX29455 Sham Lampalizumab Participants who were administered sham comparator in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months. GX29455 Lampalizumab Lampalizumab Participants who were administered lampalizumab in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months. CFD4870g Sham Lampalizumab Participants who were administered sham comparator in Study NCT01229215 (CFD4870g), will receive lampalizumab 10 milligrams (mg), intravitreally (ITV), either once in every 4 weeks (Q4W) or once in every 8 weeks (Q8W) in accordance with their previously assigned treatment frequency assignment in Study CFD4870g followed by Q4W administration for the remainder of the extension study up to approximately 96 months.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs) From Day 1 up to the last study visit (up to approximately 62 months) An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are events localized to the eye. Non-ocular events include all other events.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (46)
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
St. Franziskus Hospital
🇩🇪Munster, Germany
Universitatsklinikum Leipzig
🇩🇪Leipzig, Germany
Charleston Neuroscience Institute
🇺🇸Ladson, South Carolina, United States
Southeastern Retina Associates
🇺🇸Knoxville, Tennessee, United States
Retina Centers P.C.
🇺🇸Tucson, Arizona, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, 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
San Diego Retina Associates
🇺🇸Oceanside, California, United States
Colorado Retina Associates, PC
🇺🇸Golden, Colorado, United States
Retina Group of Florida
🇺🇸Boca Raton, Florida, United States
California Retina Consultants
🇺🇸Santa Barbara, California, United States
Retina Macula Institute
🇺🇸Torrance, California, 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
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Eye Associates of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Vitreoretinal Surgery
🇺🇸Edina, Minnesota, United States
The Retina Institute
🇺🇸Saint Louis, Missouri, United States
Opthalmic Consultants of LI
🇺🇸Lynbrook, New York, United States
Char Eye Ear &Throat Assoc
🇺🇸Charlotte, North Carolina, United States
Retina Assoc of Cleveland Inc
🇺🇸Beachwood, Ohio, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
W Texas Retina Consultants PA
🇺🇸Abilene, Texas, United States
Wagner Macula & Retina Center
🇺🇸Norfolk, Virginia, United States
Universitatsklinikum Bonn; Medizinische Klinik und Poliklinik III
🇩🇪Bonn, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Universitätsklinikum Tübingen
🇩🇪Tuebingen, Germany
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Loma Linda University
🇺🇸Loma Linda, California, United States
Western Carolina Retinal Associate PA
🇺🇸Asheville, North Carolina, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
West Coast Retina
🇺🇸San Francisco, California, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Dean McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Retina Northwest
🇺🇸Portland, Oregon, United States
W Coast Retina Med Group Inc
🇺🇸San Francisco, California, United States
Tennessee Retina PC
🇺🇸Nashville, Tennessee, United States
Elman Retina Group
🇺🇸Baltimore, Maryland, United States
Retina Research Center
🇺🇸Austin, Texas, United States