Age-related Macular Degeneration (AMD) Clinical Trial
Official title:
An Open-label Single Ascending Dose and Randomized Double-Masked, Ranibizumab Controlled, Safety, Tolerability, and Efficacy Study of Intravitreal LMG324 in Subjects With Neovascular Age-Related Macular Degeneration
Verified date | June 2019 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 25 |
Est. completion date | May 20, 2016 |
Est. primary completion date | February 29, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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 judgment). SAD population only - Presence of any contraindications, in the Investigator's opinion, to IVT anti-VEGF therapeutic administration. Enrollment expansion population only - Study eye: subject has received any approved or investigational treatment for exudative (wet) AMD other than vitamin supplements. - Study eye: any current or history of macular or retinal disease other than exudative AMD - Study eye: serous pigment epithelial detachment (PED) under the foveal center or retinal pigment epithelium (RPE) tear/rip. - Study eye: any concurrent intraocular condition (eg, cataract, diabetic retinopathy) that, in the opinion of the Investigator, could either require medical or surgical intervention during the course of the study. - Study eye: other ocular diseases that, in the opinion of the Investigator, can compromise the visual acuity - Study eye: Surgery, as specified in the protocol. |
Country | Name | City | State |
---|---|---|---|
United States | Call Alcon Call Center for Trial Locations | Fort Worth | Texas |
Lead Sponsor | Collaborator |
---|---|
Alcon Research | Novartis Institutes for BioMedical Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change from baseline in best corrected visual acuity (BCVA) at Day 85 | Baseline, Day 85 | ||
Secondary | Percentage of LMG324-treated subjects with no identified SoC treatment need up to and including Day 85 | Up to Day 85 | ||
Secondary | Best Corrected Visual Acuity (BCVA) | Up to Day 169 | ||
Secondary | Central subfield thickness total (CSFTtot) | Up to Day 169 | ||
Secondary | Central subfield thickness neuro-retina (CFSTnr) | Up to Day 169 | ||
Secondary | Lesion thickness | Up to Day 169 | ||
Secondary | Subretinal fluid with foveal involvement (SRFfi) thickness | Up to Day 169 | ||
Secondary | Retinal pigment epithelial detachment with foveal involvement (PEDfi) thickness | Up to Day 169 | ||
Secondary | Area of lesion (associated with CNV) | Up to Day 169 | ||
Secondary | Area of CNV within a lesion | Up to Day 169 | ||
Secondary | Area under the plasma concentration-time curve from time zero to infinity (AUCinf) | Up to Day 169 | ||
Secondary | Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | Up to Day 169 | ||
Secondary | Area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration (AUC0-t) | Up to Day 169 | ||
Secondary | Maximum observed maximum plasma concentration (Cmax) | Up to Day 169 | ||
Secondary | Time to reach the maximum observed plasma concentration (Tmax) | Up to Day 169 | ||
Secondary | Observed maximum plasma concentration following drug administration, by dose (Cmax/D) | Up to Day 169 | ||
Secondary | Area under the plasma concentration-time curve divided by dose (AUC/D) | Up to Day 169 | ||
Secondary | Frequency of subjects with anti-LMG324 antibodies | Up to Day 169 |
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