Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

An Extension Study to Evaluate the Long-Term Safety of FCFD4514S in Patients With Geographic Atrophy

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: May 16, 2012
Last updated: November 4, 2014
Last verified: November 2014

This extension to study CFD4870g (GX01456) will assess the long-term safety and tolerability of repeated intravitreal administration of FCFD4514S in patients wi th geographic atrophy. Patients are eligible to participate who have completed t he 18 month treatment assignment for study CFD4870g (GX01456), and meet GX28198 eligibility criteria. The anticipated time on study treatment is 18 months.

Condition Intervention Phase
Geographic Atrophy
Drug: FCFD4514S
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of FCFD4514S in Patients With Geographic Atrophy

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Long-term safety: Incidence of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: May 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: FCFD4514S
Repeating intravitreal injection
Experimental: Arm B Drug: FCFD4514S
Repeating intravitreal injection


Ages Eligible for Study:   60 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previous enrollment and completion of study CFD4870g (GX01456) without early treatment discontinuation
  • Sufficiently clear ocular media, adequate pupillary dilation, and fixation

Exclusion Criteria:

  • Early treatment and/or study discontinuation prior to completion of study CFD4870g (GX01456)
  • Vitrectomy surgery, submacular surgery, or other surgical intervention for 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
  • Intravitreal drug delivery other than FCFD4514S in the study eye
  • Active wet AMD in either eye that requires anti-VEGF treatment
  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 identifier: NCT01602120

  Hide Study Locations
United States, Arizona
Tucson, Arizona, United States, 85704
United States, California
Beverly Hills, California, United States, 90211
San Francisco, California, United States, 94107
Santa Barbara, California, United States, 93103
Torrance, California, United States, 90503
United States, Florida
Baco Ranton, Florida, United States, 33431
Palm Beach Gardens, Florida, United States, 33410
Pensacola, Florida, United States, 32503
Winter Haven, Florida, United States, 33880
United States, Georgia
Augusta, Georgia, United States, 30909
United States, Massachusetts
Boston, Massachusetts, United States, 02114
United States, Minnesota
Edina, Minnesota, United States, 55435
United States, New York
Lynbrook, New York, United States, 11563
United States, North Carolina
Charlotte, North Carolina, United States, 28210
United States, Ohio
Beachwood, Ohio, United States, 44122
Cincinnati, Ohio, United States, 45242
United States, Oregon
Portland, Oregon, United States, 97210
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Abilene, Texas, United States, 79606
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75231
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Bonn, Germany, 53127
Freiburg, Germany, 79106
Leipzig, Germany, 04103
Munster, Germany, 48145
Tuebingen, Germany, 72076
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc. Identifier: NCT01602120     History of Changes
Other Study ID Numbers: GX28198
Study First Received: May 16, 2012
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Geographic Atrophy
Eye Diseases
Macular Degeneration
Pathological Conditions, Anatomical
Retinal Degeneration
Retinal Diseases processed this record on November 25, 2014