Expired Study
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Fort Worth, Texas 76134


Purpose:

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).


Study summary:

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.


Criteria:

Inclusion Criteria: - Must give written informed consent, be able to make the required study visits and follow instructions. - Male and non-child bearing potential females. - Untreated or previously treated choroidal neovascularization (CNV) lesion due to age-related macular degeneration (AMD). - Best corrected visual acuity (BCVA) of approximately 20/200 Snellen or better in the non-study eye. SAD population only: - CNV lesion due to AMD - either treatment naïve or previously treated - that can be expected to benefit from anti-VEGF therapy, in the study eye. - At least 3 administrations of any 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, in previously treated eyes. Enrollment expansion population only: - Untreated and active CNV lesion due to AMD, in the study eye. - BCVA between 73 - 23 letters, inclusive (approximate Snellen equivalent 20/40 - 20/320), in the study eye. - Other protocol-specified inclusion criteria may apply. Exclusion Criteria: - Either eye: Active ocular infection or active intraocular inflammation. - Study eye: Current vitreous hemorrhage or a history of rhegmatogenous retinal detachment; uncontrolled glaucoma. SAD population only: - Any contraindications to IVT anti-VEGF therapeutic administration. Enrollment expansion population only: - Study Eye: Any approved or investigational treatment for exudative AMD other than vitamin supplements; any macular or retinal disease other than exudative AMD; any intraocular condition that could require medical or surgical intervention during the study or limit the potential to gain visual acuity upon treatment with the investigational product; ocular diseases that can compromise visual acuity. - Other protocol-specified exclusion criteria may apply.


NCT ID:

NCT02398500


Primary Contact:

Study Director
Clinical Scientist I, NIBR
Alcon Research


Backup Contact:

N/A


Location Contact:

Fort Worth, Texas 76134
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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