A Phase 1/2 interventional study of LMG324 and Ranibizumab 0.5 mg in Age-related Macular Degeneration (AMD), sponsored by Alcon Research. Terminated at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-06-05.
Sponsored by Alcon Research · Phase 1/2, Interventional, and Treatment
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).
The study will start with a single dose ascending (SAD) phase. LMG324 will be administered on Day 1 with no further treatment until implementation of standard of care (SoC) therapy. SoC therapy is ranibizumab 0.5 mg administered per label. Dose groups will be implemented sequentially to allow for safety review between the current and subsequent dose group. All treatments will be open-label, including ranibizumab used as SoC therapy.
In the enrollment expansion phase, subjects randomized to LMG324 arm will receive a single LMG324 IVT injection on Day 1 followed by sham (fake) IVT injections until implementation of SoC therapy. After implementation, SoC therapy will be applied monthly with sham injections applied at the interim planned visits. The enrollment expansion phase may start at a selected dose level whilst the dose escalation phase is still ongoing.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 25 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
SAD population only:
Enrollment expansion population only
Exclusion Criteria:
SAD and enrollment expansion population
SAD population only
Enrollment expansion population only
SAD: LMG324 administered as a single IVT injection in 1 eye (study eye) in 1 of 4 doses, with 15-day follow-up
Biological: LMG324
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
Biological: LMG324 · Biological: Sham
Expansion: Ranibizumab 0.5 mg administered as monthly IVT injections in 1 eye (study eye) with interim sham injections, for 24 weeks
Biological: Ranibizumab 0.5 mg · Biological: Sham
IVT injection
IVT injection
Also known as: Lucentis®
Fake injection used for masking purposes
Mean change from baseline in best corrected visual acuity (BCVA) at Day 85
Time frame: Baseline, Day 85
Percentage of LMG324-treated subjects with no identified SoC treatment need up to and including Day 85
Time frame: Up to Day 85
Best Corrected Visual Acuity (BCVA)
Time frame: Up to Day 169
Central subfield thickness total (CSFTtot)
Time frame: Up to Day 169
Central subfield thickness neuro-retina (CFSTnr)
Time frame: Up to Day 169
Lesion thickness
Time frame: Up to Day 169
Subretinal fluid with foveal involvement (SRFfi) thickness
Time frame: Up to Day 169
Retinal pigment epithelial detachment with foveal involvement (PEDfi) thickness
Time frame: Up to Day 169
Area of lesion (associated with CNV)
Time frame: Up to Day 169
Area of CNV within a lesion
Time frame: Up to Day 169
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Time frame: Up to Day 169
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Up to Day 169
Area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration (AUC0-t)
Time frame: Up to Day 169
Maximum observed maximum plasma concentration (Cmax)
Time frame: Up to Day 169
Time to reach the maximum observed plasma concentration (Tmax)
Time frame: Up to Day 169
Observed maximum plasma concentration following drug administration, by dose (Cmax/D)
Time frame: Up to Day 169
Area under the plasma concentration-time curve divided by dose (AUC/D)
Time frame: Up to Day 169
Frequency of subjects with anti-LMG324 antibodies
Time frame: Up to Day 169
This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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