This trial is active, not recruiting.

Condition geographic atrophy
Treatment fcfd4514s
Phase phase 2
Sponsor Genentech, Inc.
Start date May 2012
End date June 2019
Trial size 124 participants
Trial identifier NCT01602120, GX28198


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Repeating intravitreal injection
Repeating intravitreal injection

Primary Outcomes

Long-term safety: Incidence of adverse events
time frame: 18 months

Eligibility Criteria

Male or female participants from 60 years up to 89 years old.

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

Additional Information

Official title A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of FCFD4514S in Patients With Geographic Atrophy
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Genentech, Inc..