Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops , an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor (AhR): The LION Study

Quan Dong Nguyen1 个研究点分布在 1 个国家目标入组 12 人开始时间: 2024年5月3日最近更新: 2025年5月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 12
试验地点: 1
主要终点: Concentration of Laquinimod in aqueous humor and vitreous samples of human participants

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The LION Study is a prospective, single-center phase 1 clinical trial to evaluate the safety, tolerability, and distribution of Laquinimod administered as topical eye drops for two weeks in human participants.

详细描述

Participants who fulfill the study eligibility criteria and who are planned to undergo a pars plana vitrectomy will be enrolled in the study. Eligible participants scheduled for a diagnostic vitrectomy may also be enrolled.

The study will consist of two stages:

Stage One - Open label dose escalation:

Up to three subsequent dose-escalation groups will receive Laquinimod eye drops for 2 weeks and samples will be assayed for Laquinimod concentration in aqueous humor, vitreous and plasma.

Stage Two- Randomized, Controlled Comparison of 2 Laquinimod doses:

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age 18 years or older
•Participants who are capable and willing to provide informed consent and follow study instructions.
•Participants who are scheduled to undergo pars plana vitrectomy (PPV).
•Participants with intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in study eye
•Women who are not pregnant or lactating, are post-menopausal or have undergone a sterilization procedure.

排除标准

•Participants with active periocular or ocular infectious disease (e.g., blepharitis, scleritis, or conjunctivitis, keratitis or endophthalmitis).
•Participants with active infectious uveitis
•Participants with a history of prior intraocular or extraocular surgery within 90 days of study enrollment
•Participant with a history of intravitreal steroids administered to the study eye within 90 days of enrollment.
•Participants with a history of intravitreal injection of VEGF inhibitors within 30 days of enrollment
•Use of any topical cyclosporine or corticosteroid or other specified (i.e. calcineurin inhibitors) ophthalmic medication in the study eye for any reason within 14 days of enrollment and before the surgery
•Use of medication consisting of a strong or moderate inhibitor of CYP3A4 within 2 weeks of Baseline visit (and during the study).
•Use of medication consisting of a strong inducer of CYP3A4 within 2 weeks of Baseline visit (and during the study)
•Mild, moderate, or severe hepatic impairment (any of Child-Pugh Score A, B, and C)
•Moderate or severe renal impairment (GFR ≤60 mL/min)
•History of HIV disease or other immunodeficiency disorder
•History of acute hepatitis A (IgM positive), hepatitis B, or hepatitis C
•History of organ or bone marrow transplant
•Presence of malignancy under active treatment
•Any other acute or chronic medical condition that would, in the judgment of the study investigators, reasonably preclude participation in the clinical study
•Already enrolled in a clinical trial.
•Any condition that would prevent the investigator from acquiring images of the eye as required per protocol

研究组 & 干预措施

Group 1

Experimental

(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops once a day (0.6mg per day) in the study eye for 14 days before the surgery.