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

This study is currently recruiting participants.
Verified February 2013 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01602120
First received: May 16, 2012
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Geographic Atrophy
 Drug: FCFD4514S
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of FCFD4514S in Patients With Geographic Atrophy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Long-term safety: Incidence of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A Drug: FCFD4514S
Repeating intravitreal injection
Experimental: Arm B Drug: FCFD4514S
Repeating intravitreal injection

  Eligibility

Ages Eligible for Study:   60 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602120

Contacts
Contact: Please reference Study ID Number: GX28198 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 28 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01602120     History of Changes
Other Study ID Numbers: GX28198
Study First Received: May 16, 2012
Last Updated: February 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrophy
Geographic Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013