This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01602120
First received: May 16, 2012
Last updated: September 13, 2017
Last verified: September 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: None (Open Label)
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 96 months ]
  • Percentage of Participants (Enrolled From Study GX29455) With Ocular and Non-Ocular AEs [ Time Frame: From Day 1 up to approximately 54 months ]

Secondary Outcome Measures:
  • Serum Concentrations of Lampalizumab [ Time Frame: From Day 1 up to approximately 96 months (for participants enrolled from study CFD4870g); From Day 1 up to approximately 54 months (for participants enrolled from study GX29455) ]

Enrollment: 159
Actual Study Start Date: May 29, 2012
Estimated Study Completion Date: March 28, 2022
Estimated Primary Completion Date: June 29, 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 and again by additional 30 months for a total treatment period of 96 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 and again by additional 30 months for a total treatment period of 96 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 54 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

  Hide Study Locations
Locations
United States, Arizona
Retina Centers P.C.
Tucson, Arizona, United States, 85704
United States, California
Retina-Vitreous Assoc Med Grp
Beverly Hills, California, United States, 90211
Retinal Diagnostic Center
Campbell, California, United States, 95008
The Retina Partners
Encino, California, United States
Loma Linda University
Loma Linda, California, United States, 92354
San Diego Retina Associates
Oceanside, California, United States, 92056
W Coast Retina Med Group Inc
San Francisco, California, United States, 94107
West Coast Retina
San Francisco, California, United States, 94107
California Retina Consultants
Santa Barbara, California, United States, 93103
Retina Macula Institute
Torrance, California, United States, 90503
United States, Colorado
Colorado Retina Associates, PC
Golden, Colorado, United States, 80201
United States, Florida
Retina Group of Florida
Boca Raton, Florida, United States, 33431
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Florida Eye Associates
Melbourne, Florida, United States, 32901
Retina Care Specialists
Palm Beach Gardens, Florida, United States, 33410
Retina Specialty Institute
Pensacola, Florida, United States, 32503
Ctr for Retina & Macular Dis
Winter Haven, Florida, United States, 33880
United States, Georgia
Southeast Retina Center
Augusta, Georgia, United States, 30909
United States, Iowa
Wolfe Eye Clinic
West Des Moines, Iowa, United States, 50266
United States, Maryland
Elman Retina Group
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Minnesota
Vitreoretinal Surgery
Edina, Minnesota, United States, 55435
United States, Missouri
The Retina Institute
Saint Louis, Missouri, United States, 63144
United States, Nevada
Sierra Eye Associates
Reno, Nevada, United States, 89502
United States, New Mexico
Eye Associates of New Mexico
Albuquerque, New Mexico, United States, 87102
United States, New York
Opthalmic Consultants of LI
Lynbrook, New York, United States, 11563
United States, North Carolina
West Carolina Retinal AssocPA
Asheville, North Carolina, United States, 28803
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, United States, 28210
United States, Ohio
Retina Assoc of Cleveland Inc
Beachwood, Ohio, United States, 44122
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73099
United States, Oregon
Retina Northwest
Portland, Oregon, United States, 97221
United States, Pennsylvania
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Charleston Neuroscience Institute
Ladson, South Carolina, United States, 29456
United States, Tennessee
Southeastern Retina Associates
Chattanooga, Tennessee, United States, 37421
Tennessee Retina PC
Nashville, Tennessee, United States, 37203
United States, Texas
W Texas Retina Consultants PA
Abilene, Texas, United States, 79606
Retina Research Center
Austin, Texas, United States, 78705
Texas Retina Associates
Dallas, Texas, United States, 75231
United States, Virginia
Wagner Macula & Retina Center
Virginia Beach, Virginia, United States, 23454
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Germany
Universitatsklinikum Bonn; Medizinische Klinik und Poliklinik III
Bonn, Germany, 53127
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
St. Franziskus Hospital
Munster, Germany, 48145
Universitätsklinikum Tübingen
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: September 13, 2017

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 September 21, 2017