Clinical Trial: An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab (FCFD4514S) in Patients With Geographic Atrophy Who Have Comple
Brief Summary: This is a multicenter, open-label extension study of safety and tolerability of lampalizumab administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week treatment in Study GX29455 (NCT02288559).
Detailed Summary:
Sponsor: Genentech, Inc.
Current Primary Outcome:
- Percentage of Participants (Enrolled From Study CFD4870g) With Ocular and Non-Ocular Adverse Events (AEs) [ Time Frame: From Day 1 up to approximately 66 months ]
- Percentage of Participants (Enrolled From Study GX29455) With Ocular and Non-Ocular AEs [ Time Frame: From Day 1 up to approximately 24 months ]
Original Primary Outcome: Long-term safety: Incidence of adverse events [ Time Frame: 18 months ]
Current Secondary Outcome: Serum Concentrations of Lampalizumab [ Time Frame: From Day 1 up to approximately 66 months (for participants enrolled from study CFD4870g); From Day 1 up to approximately 24 months (for participants enrolled from study GX29455) ]
Original Secondary Outcome:
Information By: Genentech, Inc.
Dates:
Date Received: May 16, 2012
Date Started: May 31, 2012
Date Completion: June 30, 2019
Last Updated: May 10, 2017
Last Verified: May 2017
