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

NCT02398500 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-06-05

No results posted yet for this 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).

Conditions

  • Age-related Macular Degeneration (AMD)

Interventions

BIOLOGICAL

LMG324

IVT injection

BIOLOGICAL

Ranibizumab 0.5 mg

IVT injection

BIOLOGICAL

Sham

Fake injection used for masking purposes

Sponsors & Collaborators

  • Novartis Institutes for BioMedical Research

    collaborator OTHER

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Clinical Scientist I, NIBR · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02398500 on ClinicalTrials.gov