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

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01229215
First received: October 25, 2010
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-co ntrolled study of safety, tolerability, and evidence of activity of FCFD4514S i ntravitreal injections administered monthly or every other month in patients wit h geographic atrophy.


Condition Intervention Phase
Geographic Atrophy
Drug: FCFD4514S
Drug: sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Growth rate of geographic atrophy (GA) lesion area from baseline [ Time Frame: Month 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in best corrected visual acuity (BCVA) from baseline [ Time Frame: Month 18 ] [ Designated as safety issue: No ]

Enrollment: 143
Study Start Date: February 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: FCFD4514S
Repeating intravitreal injection
Sham Comparator: B Drug: sham
Repeating sham injection

  Eligibility

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

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
  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: NCT01229215

  Hide Study Locations
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
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
Germany
Bonn, Germany, 53127
Freiburg, Germany, 79106
Heidelberg, Germany, 69120
Leipzig, Germany, 04103
Munster, Germany, 48145
Tuebingen, Germany, 72076
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Erich Strauss, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01229215     History of Changes
Other Study ID Numbers: CFD4870g, GX01456
Study First Received: October 25, 2010
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrophy
Geographic Atrophy
Eye Diseases
Macular Degeneration
Pathological Conditions, Anatomical
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014