Select Your Region
Americas
Europa
Afrika
Weltweit
Langzeitsicherheit von intravitrealen (ITV) Lampalizumab-Injektionen bei Teilnehmenden mit geographischer Atrophie (GA) infolge altersbedingter Makuladegeneration (OMASPECT)
Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
- Augenerkrankung
- Trockene Makuladegeneration
- fortgeschrittene trockene AMD
- Altersbedingte Makuladegeneration
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Beendet
Diese Studie läuft in
Städte
- Bonn
- Freiburg im Breisgau
- Hannover
- Heidelberg
- Köln
- Ludwigshafen am Rhein
- Lübeck
- München
- Münster
- Regensburg
- Tübingen
Studien-ID:
NCT02745119 2016-000423-13 GX30191
Studienzusammenfassung
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
Studien-ID
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
Einschlusskriterien
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
Um die aktuellste Version dieser Seite aufzurufen gehen Sie bitte auf www.Klinische-studien-für-patienten.de
