We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01229215
Recruitment Status : Completed
First Posted : October 27, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered monthly or every other month in patients with geographic atrophy.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Drug: FCFD4514S Drug: sham Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase Ib/II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Intravitreal Injections Administered Monthly or Every Other Month to Patients With Geographic Atrophy
Study Start Date : February 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Experimental: FCFD4514S Drug: FCFD4514S
Repeating intravitreal injection

Sham Comparator: sham Drug: sham
Repeating sham injection

Primary Outcome Measures :
  1. Growth rate of geographic atrophy (GA) lesion area from baseline [ Time Frame: Month 18 ]

Secondary Outcome Measures :
  1. Mean change in best corrected visual acuity (BCVA) from baseline [ Time Frame: Month 18 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   60 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Willingness and ability to provide signed Informed Consent; in addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws
  • Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)

Exclusion Criteria:

  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
  • Previous subfoveal focal laser photocoagulation in the study eye
  • Laser photocoagulation in the study eye
  • Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
  • GA in either eye due to causes other than AMD
  • Diabetic retinopathy in either eye
  • Active or history of wet AMD in either eye
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
  • Active malignancy or history of malignancy within the past 5 years
  • Previous participation in any studies of investigational drugs within 3 months preceding Day 0

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229215

Layout table for location information
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
Boynton Beach, Florida, United States, 33426
Fort Lauderdale, Florida, United States, 33334
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, Kentucky
Paducah, Kentucky, United States, 42001
United States, Maryland
Baltimore, Maryland, United States, 21287
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
New York, New York, United States, 10003
Rochester, New York, United States, 14642
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, 19104
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
West Columbia, South Carolina, United States, 29169
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
Heidelberg, Germany, 69120
Leipzig, Germany, 04103
Munster, Germany, 48145
Tuebingen, Germany, 72076
Sponsors and Collaborators
Genentech, Inc.
Layout table for investigator information
Study Director: Erich Strauss, M.D. Genentech, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01229215    
Other Study ID Numbers: CFD4870g
GX01456 ( Other Identifier: Hoffmann-La Roche )
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Geographic Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases