drugset / Trial / NCT02398500

Safety Tolerability and Efficacy of Intravitreal LMG324 in the Treatment of Neovascular Age-Related Macular Degeneration

NCT02398500

RandomizedSequentialDouble-blindTreatment

Summary

The purpose of this first-in-human study is to evaluate the safety and tolerability of single ascending doses of LMG324 to determine the maximum tolerated dose (MTD) in neovascular age-related macular degeneration (nvAMD) subjects. Enrollment will be expanded at a safe and tolerated dose in treatment naïve nvAMD subjects to compare a single intravitreal (IVT) dose of LMG324 to ranibizumab 0.5 mg administered every 4 weeks for change from baseline in best-corrected visual acuity (BCVA) at Week 12 (Day 85).

Timeline

Start
2015-07-22
Primary completion
2016-02-29
Completion
2016-05-20

Drugs

EvaluationDrugModalityDoseRoute
Subject LMG324 Unknown Intravitreal
Comparator Ranibizumab Monoclonal antibody 0.5 mg Intravitreal