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

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
Alcon Research
Study ID
NCT02398500
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Age-related Macular Degeneration (AMD)

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LMG324 — BIOLOGICAL
    IVT injection
  • Ranibizumab 0.5 mg — BIOLOGICAL
    IVT injection
  • Sham — BIOLOGICAL
    Fake injection used for masking purposes

Study Details

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).

Key Dates

First listed
Mar 25, 2015
Start date
Jul 22, 2015
Status verified
Jun 2019
Primary completion
Feb 29, 2016
Completion
May 20, 2016

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: LMG324
    SAD: LMG324 administered as a single IVT injection in 1 eye (study eye) in 1 of 4 doses, with 15-day follow-up
  • Experimental: LMG324 + sham
    Expansion: LMG324 administered as a single IVT injection in 1 eye (study eye), followed by sham injections, until implementation of SoC therapy as specified in the protocol, for 24 weeks
  • Active Comparator: Lucentis + sham
    Expansion: Ranibizumab 0.5 mg administered as monthly IVT injections in 1 eye (study eye) with interim sham injections, for 24 weeks

Primary Outcome Measure

Mean change from baseline in best corrected visual acuity (BCVA) at Day 85 [ Time Frame: Baseline, Day 85 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Call Alcon Call Center for Trial LocationsFort WorthTexas76134-

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