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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01229215
First Posted: October 27, 2010
Last Update Posted: November 2, 2016
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.
Information provided by (Responsible Party):
Genentech, Inc.
October 25, 2010
October 27, 2010
November 2, 2016
February 2011
April 2013   (Final data collection date for primary outcome measure)
Growth rate of geographic atrophy (GA) lesion area from baseline [ Time Frame: Month 18 ]
Growth rate of geographic atrophy (GA) lesion area from baseline [ Time Frame: Month 12 ]
Complete list of historical versions of study NCT01229215 on ClinicalTrials.gov Archive Site
Mean change in best corrected visual acuity (BCVA) from baseline [ Time Frame: Month 18 ]
Same as current
Not Provided
Not Provided
 
A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Geographic Atrophy
  • Drug: FCFD4514S
    Repeating intravitreal injection
  • Drug: sham
    Repeating sham injection
  • Experimental: FCFD4514S
    Intervention: Drug: FCFD4514S
  • Sham Comparator: sham
    Intervention: Drug: sham

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
143
April 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
60 Years to 89 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States
 
 
NCT01229215
CFD4870g
GX01456 ( Other Identifier: Hoffmann-La Roche )
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Erich Strauss, M.D. Genentech, Inc.
Genentech, Inc.
November 2016

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