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 May 2016 by Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: May 16, 2012
Last updated: May 4, 2016
Last verified: May 2016
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: Crossover 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

Further study details as provided by Genentech, Inc.:

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 2016
Estimated Primary Completion Date: November 2016 (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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01602120

Contact: Reference Study ID Number: GX28198 888-662-6728 (U.S. and Canada)

  Show 40 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT01602120     History of Changes
Other Study ID Numbers: GX28198 
Study First Received: May 16, 2012
Last Updated: May 4, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Geographic Atrophy
Eye Diseases
Macular Degeneration
Pathological Conditions, Anatomical
Retinal Degeneration
Retinal Diseases processed this record on May 04, 2016