Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
- Age-Related Macular Degeneration
Trial Status:
This trial runs in
Cities
- 'Aiea
- Abilene
- Albacete
- Albany
- Albury
- Ankara
- Ann Arbor
- Arlington
- Asheville
- Ashland
- Augusta
- Aurora
- Austin
- Bakersfield
- Baltimore
- Barcelona
- Belfast
- Bellevue
- Bern
- Beverly Hills
- Bilbao
- Binningen
- Birmingham
- Bloomfield
- Boisbriand
- Bonn
- Bordeaux
- Boston
- Box Hill
- Boynton Beach
- Bradford
- Bratislavský kraj
- Bristol
- Bruxelles
- Budapest
- Bydgoszcz
- Bytom
- Cardiff
- Charlotte
- Charlottesville
- Chattanooga
- Cherry Hill
- Chesterfield
- Chevy Chase
- Cincinnati
- Cleveland
- Coimbra
- Colorado Springs
- Columbus
- Créteil
- Dallas
- Debrecem
- Detroit
- Durham
- East Melbourne
- Edina
- Edison
- Florence
- Fort Lauderdale
- Fort Myers
- Freiburg
- Fullerton
- Gdańsk
- Genova
- Germantown
- Glostrup
- Gloucestershire
- Golden
- Grand Rapids
- Hannover
- Hauppauge
- Heidelberg
- Henderson
- Houston
- Indianapolis
- Katowice
- Kraków
- Köln
- L'Hospitalet de Llobregat
- La Jolla
- Ladson
- Las Vegas
- Lawrenceville
- Leiden
- Leuven
- Lexington
- Lima
- Linz
- Lisboa
- Liverpool
- Los Angeles
- Ludwigshafen
- Lynbrook
- Lyon
- Lübeck
- Madison
- Madrid
- Manchester
- Marietta
- Marseille
- McAllen
- Melbourne
- Milano
- Monroeville
- Morgantown
- Mountain View
- München
- Münster
- Nantes
- Naples
- Nashville
- New London
- New York
- Newcastle upon Tyne
- Northfield
- Oakland
- Paducah
- Palm Beach Gardens
- Palm Desert
- Palo Alto
- Pamplona
- Paris
- Parramatta
- Pensacola
- Phoenix
- Plantation
- Portland
- Poway
- Pécs
- Rapid City
- Regensburg
- Reno
- Richmond
- Rochester
- Roma
- Roskilde
- Royal Oak
- Sacramento
- Saint Petersburg
- Salt Lake City
- San Francisco
- Santa Ana
- Santa Barbara
- Santiago de Compostela
- Shawnee Mission
- Silverdale
- Southampton
- Southfield
- Spokane
- Sydney
- Syracuse
- Tallahassee
- Tampa
- Teaneck
- Temple
- The Woodlands
- Torino
- Towson
- Trencin
- Tucson
- Tübingen
- Udine
- Valladolid
- València
- Walnut Creek
- Warrenton
- West Des Moines
- West Mifflin
- Westmead
- Wichita
- Wien
- Willow Park
- Winston-Salem
- Wolverhampton
- Worcester
- Wrocław
- York
- Zilina
- Zürich
- Łódź
Trial Identifier:
NCT02745119 2016-000423-13 GX30191
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02745119 , GX30191 , 2016-000423-13
Trial Identifier
Lampalizumab
Treatments
Geographic Atrophy
Condition
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
Eligibility Criteria
All
Gender
No
Healthy Volunteers
Inclusion Criteria
- 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
Exclusion Criteria
- 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
For the latest version of this information please go to www.forpatients.roche.com