NOV 06, 2017
Anti-Amyloid Beta Monoclonal Antibody to Treat GA Secondary to AMD: Phase 2 Results
Retina Subspecialty Day 2016
Macular Disease, Retina/Vitreous
Dr. Philip Rosenfeld presents the results of this phase 2 study:
Safety
- There was no safety signal that would preclude continued investigation.
- After extensive MRI monitoring, amyloid-related imaging abnormalities, edema detected, were low (< 1%).
PK/PD
- Exposure to GSK933776 increased proportional to dose.
- Free Aβ decreased with near maximum reduction observed in the 15 mg/kg arm.
Efficacy
- There was no slowing of GA enlargement rate with GSK933776 in the primary analysis or among prospectively defined subpopulations.
- There was no clinically meaningful slowing of decline relative to placebo in visual function measures.
Pharmacogenetics and Low Luminance Deficits
- "CFI" genetic biomarker (rs17440077) status did not have a have a significant affect on GA enlargement rate.
- LLVA deficit at BL correlated with GA enlargement rate overall.