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Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

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 Macular Degeneration Who Have Completed a Roche-Sponsored Study

Keywords

Geographic Atrophy Immunoglobulin Fab Fragments

Eligibility

You can join if…

  • Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit
  • Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential

You CAN'T join if...

  • Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
  • Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
  • Increased risk of infection
  • Pregnancy or lactation

Locations

  • Mountain View, California, 94040, USA
  • Oakland, California, 94609, USA
  • Palo Alto, California, 94303, USA
  • Sacramento, California, 95817, USA
  • Sacramento, California, 95841, USA
  • San Francisco, California, 94107, USA
  • Walnut Creek, California, 94598, USA
  • Bakersfield, California, 93309, USA
  • Beverly Hills, California, USA
  • Fullerton, California, 92835, USA
  • La Jolla, California, 92093, USA
  • Los Angeles, California, 90095, USA
  • Palm Desert, California, 92211, USA
  • Poway, California, 92064, USA
  • Santa Barbara, California, 93103, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02745119
Phase
Phase 3
Study Type
Interventional
Last Updated
November 2016
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