Safety Tolerability and Efficacy of Intravitreal LMG324 in the Treatment of Neovascular Age-Relat… (NCT02398500) | Clinical Trial Compass
TerminatedPhase 1/2
Safety Tolerability and Efficacy of Intravitreal LMG324 in the Treatment of Neovascular Age-Related Macular Degeneration
Stopped: Management decision
United States25 participantsStarted 2015-07-22
Plain-language 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).
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Must give written informed consent, be able to make the required study visits and follow instructions.
* Best corrected visual acuity (BCVA) of 34 letters (approximately 20/200 Snellen or better) in the non-study eye.
SAD population only:
* Subject's study eye must have a choroidal neovascularization (CNV) lesion due to age-related macular degeneration (AMD), either treatment naïve or previously treated, that can be expected to benefit, in the opinion of the investigator, from anti-vascular endothelial growth factor (anti-VEGF) therapy.
* Previously treated eyes must have a history of least 3 administrations of any intravitreal (IVT) anti-VEGF therapeutic for the treatment of CNV with the last injection administered ≥ 1 month prior to the planned administration of the study drug.
Enrollment expansion population only
* Subject's study eye must have untreated and active CNV lesion due to AMD.
* BCVA, between 73 - 23 letters, inclusive (approximate Snellen equivalent 20/40 - 20/320) in the study eye.
Exclusion Criteria:
SAD and enrollment expansion population
* Both eyes: any active ocular or periocular infection or active intraocular inflammation (eg, infectious blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis).
* Study eye: current vitreous hemorrhage or a history of rhegmatogenous retinal detachment.
* Study eye: uncontrolled glaucoma (intraocular pressure \[IOP\] \>25 mmHg on medication or according to Investigator's…
What they're measuring
1
Mean change from baseline in best corrected visual acuity (BCVA) at Day 85