Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study

Официальное название

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

Обзор

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.

Подробное описание

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:

After the dose escalation cohorts are analysed, 2 Laquinimod doses will be selected for a randomized comparison. The doses in stage 2 will not exceed those studied in stage 1.

Вмешательства

• Препарат Laquinimod eye drops
  n Laquinimod eye drops 10 mg/ml Dose: Dosing frequency will depend on the groups assigned

Первичные конечные точки

• Concentration of Laquinimod in aqueous humor and vitreous samples of human participants [Срок оценки: After 2 weeks of study drug administration]
• Concentration of Laquinimod in plasma of human participants [Срок оценки: After 2 weeks of study drug administration]

Вторичные конечные точки (1)

• Safety Assessment [Срок оценки: Baseline to end of Study at 22-30days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Spencer Center for Vision Research at the Byers Eye Institute — Palo Alto

Публикации

• El Feky D, Akhavanrezayat A, Mobasserian A, Khan H, Elaraby O, Yavari N, Halim MS, Tram Tran AN, Khatri A, Kirimli GU, Tuong Than NT, Vahtola E, Torngren M, Hung JH, Moussa M, DeBoer C, Mruthyunjaya P, Smith S, Or C, Kabeel M, Serag Y, Do DV, Urtti A, Nguyen QD. Safety and Biodistribution of Topical Laquinimod, an Immunomodulator Targeting Aryl Hydrocarbon Receptor: The LION Study. Ophthalmol Sci. PMID 42211725

Идентификаторы

NCT: NCT06161415 · 71341

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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