An Extension Study to Evaluate the Long-Term Safety of FCFD4514S in Patients With Geographic Atrophy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01602120
First received: May 16, 2012
Last updated: September 2, 2014
Last verified: September 2014

May 16, 2012
September 2, 2014
May 2012
November 2016   (final data collection date for primary outcome measure)
Long-term safety: Incidence of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01602120 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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An Extension Study to Evaluate the Long-Term Safety of FCFD4514S in Patients With Geographic Atrophy
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of FCFD4514S in Patients With Geographic Atrophy

This extension to study CFD4870g (GX01456) will assess the long-term safety and tolerability of repeated intravitreal administration of FCFD4514S in patients wi th geographic atrophy. Patients are eligible to participate who have completed t he 18 month treatment assignment for study CFD4870g (GX01456), and meet GX28198 eligibility criteria. The anticipated time on study treatment is 18 months.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Geographic Atrophy
Drug: FCFD4514S
Repeating intravitreal injection
  • Experimental: Arm A
    Intervention: Drug: FCFD4514S
  • Experimental: Arm B
    Intervention: Drug: FCFD4514S
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
November 2016
November 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previous enrollment and completion of study CFD4870g (GX01456) without early treatment discontinuation
  • Sufficiently clear ocular media, adequate pupillary dilation, and fixation

Exclusion Criteria:

  • Early treatment and/or study discontinuation prior to completion of study CFD4870g (GX01456)
  • Vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
  • Subfoveal focal laser photocoagulation in the study eye
  • Treatment with Visodyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
  • Intravitreal drug delivery other than FCFD4514S in the study eye
  • Active wet AMD in either eye that requires anti-VEGF treatment
Both
60 Years to 89 Years
No
Contact: Reference Study ID Number: GX28198 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Germany
 
NCT01602120
GX28198
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
September 2014

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