Evaluating Laquinimod Eye Drops for Uveitis Treatment

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

This study is testing if Laquinimod eye drops are safe and effective for treating uveitis in people who are having eye surgery.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (other)
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT06161415 on ClinicalTrials.gov

What this trial studies

The LION Study is a phase 1 clinical trial designed to assess the safety, tolerability, and distribution of Laquinimod administered as topical eye drops over a two-week period. Participants scheduled for pars plana vitrectomy will be enrolled, and the study will consist of two stages: an open-label dose escalation followed by a randomized controlled comparison of selected doses. The trial aims to measure Laquinimod concentrations in the aqueous humor, vitreous, and plasma to understand its effects better.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for pars plana vitrectomy and meet specific ocular health criteria.

Not a fit: Patients with active ocular infections or those who have had recent ocular surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new topical treatment option for patients suffering from uveitis and related inflammatory conditions.

How similar studies have performed: While this approach is novel in the context of Laquinimod eye drops, similar studies have shown promise in using topical immunomodulators for ocular conditions.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Participants with active periocular or ocular infectious disease (e.g., blepharitis, scleritis, or conjunctivitis, keratitis or endophthalmitis).
2. Participants with active infectious uveitis
3. Participants with a history of prior intraocular or extraocular surgery within 90 days of study enrollment
4. Participant with a history of intravitreal steroids administered to the study eye within 90 days of enrollment.
5. Participants with a history of intravitreal injection of VEGF inhibitors within 30 days of enrollment
6. 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
7. Use of medication consisting of a strong or moderate inhibitor of CYP3A4 within 2 weeks of Baseline visit (and during the study).
8. Use of medication consisting of a strong inducer of CYP3A4 within 2 weeks of Baseline visit (and during the study)
9. Mild, moderate, or severe hepatic impairment (any of Child-Pugh Score A, B, and C)
10. Moderate or severe renal impairment (GFR ≤60 mL/min)
11. History of HIV disease or other immunodeficiency disorder
12. History of acute hepatitis A (IgM positive), hepatitis B, or hepatitis C
13. History of organ or bone marrow transplant
14. Presence of malignancy under active treatment
15. Any other acute or chronic medical condition that would, in the judgment of the study investigators, reasonably preclude participation in the clinical study
16. Already enrolled in a clinical trial.
17. Any condition that would prevent the investigator from acquiring images of the eye as required per protocol

Where this trial is running

Palo Alto, California

• Spencer Center for Vision Research at the Byers Eye Institute — Palo Alto, California, United States (RECRUITING)

Conditions: Inflammation, Uveitis, Laquinimod eye drops, Topical, Immunomodulation