Safety and Efficacy Study of ESBA1008 versus LUCENTIS®
Research type
Research Study
Full title
Safety and Efficacy Study of ESBA1008 versus LUCENTIS® for the Treatment of Exudative Age-Related Macular Degeneration
IRAS ID
79733
Contact name
Niro Narendran
Sponsor organisation
Alcon Laboratories (U.K.) Ltd
Eudract number
2011-000536-28
Clinicaltrials.gov Identifier
Research summary
This is a Phase 1 study which assesses the safety, tolerability and the effects of treatment on ocular outcomes following a single injection into the eye of ESBA1008 solution compared to Lucentis in patients with exudative (wet) Age-related Macular Degeneration. Both products are inhibitors of the Vascular Endothelial Growth Factor which is a target for treatment of exudative AMD.The safety objective that drives escalation to the next dose is the incidence of adverse events of special interest related to the Investigational Product that occur in the study eye within 7() days of the injection into the eye.The primary efficacy objective is the mean reduction from baseline through Month 1 of central subfield thickness as measured by SD-OCT.The secondary efficacy objective is the difference in duration of effect between ESBA1008 and Lucentis based on SD-OCT measured by time to receiving standard of care from Visit 2/Day 0.The supportive efficacy objective is mean change in BCVA from baseline through the time of patients?? reversion to standard of care.
REC name
North West - Haydock Research Ethics Committee
REC reference
11/NW/0292
Date of REC Opinion
3 Aug 2011
REC opinion
Further Information Favourable Opinion