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NCT02398500 · ClinicalTrials.gov registry record · Phase 1
Safety Tolerability and Efficacy of Intravitreal LMG324 in the Treatment of Neovascular Age-Related Macular Degeneration
A Phase 1 study, sponsored by Alcon Research.
- Terminated
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT02398500 is a Phase 1 study that was terminated before completion, run by Alcon Research. The registered enrollment target is 25 participants.
The verdict
NCT02398500, a Phase 1 study, was terminated before completion, sponsored by Alcon Research.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study 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).
Interventions
- BIOLOGICAL LMG324
- BIOLOGICAL Ranibizumab 0.5 mg
- BIOLOGICAL Sham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2015-07-22 |
| Est. Completion | 2016-05-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02398500
The ClinicalTrials.gov registry entry for NCT02398500 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alcon Research, which has 275 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which LMG324 is the first listed.
NCT02398500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02398500 about?
NCT02398500 is a clinical study titled "Safety Tolerability and Efficacy of Intravitreal LMG324 in the Treatment of Neovascular Age-Related Macular Degeneration". 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 treatmen...
What is the current status of trial NCT02398500?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2015-07-22. Estimated completion is 2016-05-20.
What interventions are being tested in trial NCT02398500?
The interventions under investigation include: LMG324 (BIOLOGICAL), Ranibizumab 0.5 mg (BIOLOGICAL), Sham (BIOLOGICAL).
Who is sponsoring clinical trial NCT02398500?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
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