drugset / Trial / NCT02398500
Safety Tolerability and Efficacy of Intravitreal LMG324 in the Treatment of Neovascular Age-Related Macular Degeneration
Phase 1/2
Terminated
25 enrolled
Alcon Research
Novartis Institutes for BioMedical Research · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LMG324 | Unknown | — | Intravitreal |
| Comparator | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |