GX30191 Lampalizumab open label extension in geographic atrophy
Research type
Research Study
Full 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
IRAS ID
208245
Contact name
Andrew Lotery
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2016-000423-13
Duration of Study in the UK
1 years, 11 months, days
Research summary
This study is to compare the effects, good or bad, of lampalizumab, administered to patients by intravitreal injection (an injection into your eye), on the patient and their geographic atrophy (GA). In this open-label extension study, patients will receive lampalizumab by intravitreal injection either every 4 weeks (Q4W) or every 6 weeks (Q6W).
Lampalizumab is an experimental drug, which means that health authorities have not approved lampalizumab (hereafter referred to as “study drug”) for the treatment of GA.
Patient will have geographic atrophy and will be approached if their doctor thinks they might be suitable for this study. Around 64 participants will take part in the study in the UK and 1800 worldwide.
If patients are eligible for this study, and they provide their consent to participate, they will receive study drug (lampalizumab) injections every 4 weeks or every 6 weeks. The dosing frequency will remain consistent with the dosing schedule in their current parent study (Study GX29176 or GX29185). That is, if they were originally receiving study treatment (either lampalizumab or sham [placebo] injections) every 4 weeks, then they will remain on the Q4W schedule. Similarly, if they were originally receiving study treatment Q6W, they will remain on the every 6 weeks schedule.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0542
Date of REC Opinion
25 Oct 2016
REC opinion
Favourable Opinion