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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
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE October 25, 2010
First Posted Date  ICMJE October 27, 2010
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE February 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
Growth rate of geographic atrophy (GA) lesion area from baseline [ Time Frame: Month 18 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2010)
Growth rate of geographic atrophy (GA) lesion area from baseline [ Time Frame: Month 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2010)
Mean change in best corrected visual acuity (BCVA) from baseline [ Time Frame: Month 18 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Geographic Atrophy
Intervention  ICMJE
  • Drug: FCFD4514S
    Repeating intravitreal injection
  • Drug: sham
    Repeating sham injection
Study Arms  ICMJE
  • Experimental: FCFD4514S
    Intervention: Drug: FCFD4514S
  • Sham Comparator: sham
    Intervention: Drug: sham
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2012)
143
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2010)
120
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01229215
Other Study ID Numbers  ICMJE CFD4870g
GX01456 ( Other Identifier: Hoffmann-La Roche )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Genentech, Inc.
Original Responsible Party Disclosures Group, Genentech, Inc.
Current Study Sponsor  ICMJE Genentech, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Erich Strauss, M.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP