Status:
RECRUITING
Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study
Lead Sponsor:
Quan Dong Nguyen
Collaborating Sponsors:
Global Ophthalmic Research Center (GORC)
Conditions:
Inflammation
Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 part...
Detailed Description
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 vitrectom...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06161415
Start Date
May 3 2024
End Date
July 1 2025
Last Update
May 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Spencer Center for Vision Research at the Byers Eye Institute
Palo Alto, California, United States, 94303