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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:
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

October 25, 2010
November 4, 2014
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 ] [ Designated as safety issue: No ]
Growth rate of geographic atrophy (GA) lesion area from baseline [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Mean change in best corrected visual acuity (BCVA) from baseline [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
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-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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Geographic Atrophy
  • Drug: FCFD4514S
    Repeating intravitreal injection
  • Drug: sham
    Repeating sham injection
  • Experimental: A
    Intervention: Drug: FCFD4514S
  • Sham Comparator: B
    Intervention: Drug: sham
Not Provided

*   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
Both
60 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT01229215
CFD4870g, GX01456
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Erich Strauss, M.D. Genentech, Inc.
Genentech, Inc.
November 2014

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