Clinical Trial: Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
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 in Patients With Geographic Atrophy Secondary to Age-Related Ma
Brief Summary: This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome:
- Percentage of Participants with Ocular Adverse Events (AEs) by Severity [ Time Frame: From Baseline to last dose, approximately 2 years; however, study duration may be adjusted at time of Health Authority (HA) approval in the respective country ]
- Percentage of Participants with Systemic (Non-Ocular) AEs by Severity [ Time Frame: From Baseline to last dose, approximately 2 years; however, study duration may be adjusted at time of HA approval in the respective country ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Hoffmann-La Roche
Dates:
Date Received: April 18, 2016
Date Started: July 31, 2016
Date Completion: October 31, 2019
Last Updated: May 9, 2017
Last Verified: May 2017
