Study Stopped
The study was terminated early by the Sponsor due to lack of efficacy.
An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab (FCFD4514S) in Patients With Geographic Atrophy Who Have Completed Genentech-Sponsored Lampalizumab Studies
2 other identifiers
interventional
159
2 countries
46
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2012
Longer than P75 for phase_2
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2012
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedStudy Start
First participant enrolled
May 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2018
CompletedResults Posted
Study results publicly available
February 21, 2019
CompletedSeptember 11, 2019
September 1, 2019
5.4 years
May 16, 2012
January 23, 2019
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs)
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.
From Day 1 up to the last study visit (up to approximately 62 months)
Study Arms (4)
CFD4870g Sham
EXPERIMENTALParticipants 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.
CFD4870g Lampalizumab
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants who were administered lampalizumab in Study NCT02288559 (GX29455), will receive lampalizumab 10 mg, ITV, Q4W throughout the extension study up to approximately 54 months.
Interventions
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (46)
Retina Centers P.C.
Tucson, Arizona, 85704, United States
Retina-Vitreous Assoc Med Grp
Beverly Hills, California, 90211, United States
Retinal Diagnostic Center
Campbell, California, 95008, United States
The Retina Partners
Encino, California, 91436, United States
Loma Linda University
Loma Linda, California, 92354, United States
San Diego Retina Associates
Oceanside, California, 92056, United States
W Coast Retina Med Group Inc
San Francisco, California, 94107, United States
West Coast Retina
San Francisco, California, 94107, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Retina Macula Institute
Torrance, California, 90503, United States
Colorado Retina Associates, PC
Golden, Colorado, 80401, United States
Retina Group of Florida
Boca Raton, Florida, 33431, United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912, United States
Florida Eye Associates
Melbourne, Florida, 32901, United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Ctr for Retina & Macular Dis
Winter Haven, Florida, 33880, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Elman Retina Group
Baltimore, Maryland, 21237, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Vitreoretinal Surgery
Edina, Minnesota, 55435, United States
The Retina Institute
St Louis, Missouri, 63128, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, 87102, United States
Opthalmic Consultants of LI
Lynbrook, New York, 11563, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, 28803, United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, 28210, United States
Retina Assoc of Cleveland Inc
Beachwood, Ohio, 44122, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73099, United States
Retina Northwest
Portland, Oregon, 97221, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
Charleston Neuroscience Institute
Ladson, South Carolina, 29456, United States
Southeastern Retina Associates
Knoxville, Tennessee, 37923, United States
Tennessee Retina PC
Nashville, Tennessee, 37203, United States
W Texas Retina Consultants PA
Abilene, Texas, 79606, United States
Retina Research Center
Austin, Texas, 78705, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Wagner Macula & Retina Center
Norfolk, Virginia, 23451, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Universitatsklinikum Bonn; Medizinische Klinik und Poliklinik III
Bonn, 53127, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitatsklinikum Leipzig
Leipzig, 04103, Germany
St. Franziskus Hospital
Münster, 48145, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early by the Sponsor, because the compound had demonstrated lack of efficacy. Thus, no participant in this study completed the full duration of treatment.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2012
First Posted
May 18, 2012
Study Start
May 29, 2012
Primary Completion
November 8, 2017
Study Completion
February 9, 2018
Last Updated
September 11, 2019
Results First Posted
February 21, 2019
Record last verified: 2019-09