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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

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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.

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

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
Primary Completion Date : April 2013
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

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Ages Eligible for Study:   60 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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


  Show 36 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Erich Strauss, M.D. Genentech, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01229215     History of Changes
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:
Atrophy
Geographic Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases