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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01602120
First received: May 16, 2012
Last updated: May 10, 2017
Last verified: May 2017
  Purpose
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).

Condition Intervention Phase
Geographic Atrophy
Drug: Lampalizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants (Enrolled From Study CFD4870g) With Ocular and Non-Ocular Adverse Events (AEs) [ Time Frame: From Day 1 up to approximately 66 months ]
  • Percentage of Participants (Enrolled From Study GX29455) With Ocular and Non-Ocular AEs [ Time Frame: From Day 1 up to approximately 24 months ]

Secondary Outcome Measures:
  • Serum Concentrations of Lampalizumab [ Time Frame: From Day 1 up to approximately 66 months (for participants enrolled from study CFD4870g); From Day 1 up to approximately 24 months (for participants enrolled from study GX29455) ]

Estimated Enrollment: 113
Actual Study Start Date: May 31, 2012
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lampalizumab Monthly: Study CFD4870g
Participants will receive lampalizumab 10 milligrams (mg) ITV injection monthly starting at Day 1 for up to 42 (18 + 24) months. The study treatment period has been extended by another 24 months for a total treatment period of 66 months.
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Name: FCFD4514S
Experimental: Lampalizumab Every Other Month: Study CFD4870g
Participants will receive lampalizumab 10 mg ITV injection every other month starting at Day 1 for up to 18 months. The treatment duration has been extended by 24 months and participants have been crossed over to monthly treatment arm to receive monthly lampalizumab treatment for the remainder of study treatment period. The study treatment period has been extended by another 24 months for a total treatment period of 66 months.
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Name: FCFD4514S
Experimental: Lampalizumab Monthly: Study GX29455
Participants will receive lampalizumab 10 mg ITV injection monthly starting at Day 1 for up to 24 ITV injections.
Drug: Lampalizumab
Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
Other Name: FCFD4514S

  Eligibility

Ages Eligible for Study:   60 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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 patient at high risk for treatment complications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602120

Contacts
Contact: Reference Study ID Number: GX28198 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Hide Study Locations
Locations
United States, Arizona
Retina Centers P.C. Active, not recruiting
Tucson, Arizona, United States, 85704
United States, California
Retina-Vitreous Assoc Med Grp Active, not recruiting
Beverly Hills, California, United States, 90211
Retinal Diagnostic Center Recruiting
Campbell, California, United States, 95008
The Retina Partners Recruiting
Encino, California, United States
Loma Linda University Not yet recruiting
Loma Linda, California, United States, 92354
San Diego Retina Associates Recruiting
Oceanside, California, United States, 92056
W Coast Retina Med Group Inc Completed
San Francisco, California, United States, 94107
West Coast Retina Recruiting
San Francisco, California, United States, 94107
California Retina Consultants Active, not recruiting
Santa Barbara, California, United States, 93103
Retina Macula Institute Active, not recruiting
Torrance, California, United States, 90503
United States, Colorado
Colorado Retina Associates, PC Recruiting
Golden, Colorado, United States, 80201
United States, Florida
Retina Group of Florida Active, not recruiting
Boca Raton, Florida, United States, 33431
National Ophthalmic Research Institute Recruiting
Fort Myers, Florida, United States, 33912
Florida Eye Associates Active, not recruiting
Melbourne, Florida, United States, 32901
Retina Care Specialists Active, not recruiting
Palm Beach Gardens, Florida, United States, 33410
Retina Specialty Institute Active, not recruiting
Pensacola, Florida, United States, 32503
Ctr for Retina & Macular Dis Active, not recruiting
Winter Haven, Florida, United States, 33880
United States, Georgia
Southeast Retina Center Active, not recruiting
Augusta, Georgia, United States, 30909
United States, Iowa
Wolfe Eye Clinic Active, not recruiting
West Des Moines, Iowa, United States, 50266
United States, Maryland
Elman Retina Group Not yet recruiting
Baltimore, Maryland, United States, 21237
Johns Hopkins Hospital. Withdrawn
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Ophthalmic Consultants of Boston Active, not recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
Vitreoretinal Surgery Active, not recruiting
Edina, Minnesota, United States, 55435
United States, Missouri
The Retina Institute Recruiting
Saint Louis, Missouri, United States, 63144
United States, Nevada
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
United States, New Mexico
Eye Associates of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87102
United States, New York
Opthalmic Consultants of LI Active, not recruiting
Lynbrook, New York, United States, 11563
United States, North Carolina
West Carolina Retinal AssocPA Recruiting
Asheville, North Carolina, United States, 28803
Char Eye Ear &Throat Assoc Active, not recruiting
Charlotte, North Carolina, United States, 28210
United States, Ohio
Retina Assoc of Cleveland Inc Active, not recruiting
Beachwood, Ohio, United States, 44122
Cincinnati Eye Institute Active, not recruiting
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Dean McGee Eye Institute Recruiting
Oklahoma City, Oklahoma, United States, 73099
United States, Oregon
Retina Northwest Active, not recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
Mid Atlantic Retina Active, not recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Charleston Neuroscience Institute Recruiting
Ladson, South Carolina, United States, 29456
United States, Tennessee
Southeastern Retina Associates Recruiting
Chattanooga, Tennessee, United States, 37421
Tennessee Retina PC Terminated
Nashville, Tennessee, United States, 37203
United States, Texas
W Texas Retina Consultants PA Active, not recruiting
Abilene, Texas, United States, 79606
Retina Research Center Active, not recruiting
Austin, Texas, United States, 78705
Texas Retina Associates Active, not recruiting
Dallas, Texas, United States, 75231
United States, Virginia
Wagner Macula & Retina Center Recruiting
Virginia Beach, Virginia, United States, 23454
United States, Wisconsin
Medical College of Wisconsin Completed
Milwaukee, Wisconsin, United States, 53226
Germany
Universitatsklinikum Bonn; Medizinische Klinik und Poliklinik III Active, not recruiting
Bonn, Germany, 53127
Universitätsklinikum Freiburg Active, not recruiting
Freiburg, Germany, 79106
Universität Heidelberg; Dept. Of Cardiology Withdrawn
Heidelberg, Germany, 69120
Universitätsklinikum Leipzig, Klinik und Poliklinik für Augenheilkunde Completed
Leipzig, Germany, 04103
St. Franziskus Hospital Completed
Munster, Germany, 48145
Universitätsklinikum Tübingen Terminated
Tuebingen, Germany, 72076
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01602120     History of Changes
Other Study ID Numbers: GX28198
2012-000578-41 ( EudraCT Number )
Study First Received: May 16, 2012
Last Updated: May 10, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrophy
Geographic Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017