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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
n Laquinimod eye drops 10 mg/ml Dose: Dosing frequency will depend on the groups assigned
Spencer Center for Vision Research at the Byers Eye Institute
Palo Alto, California, United States
RECRUITINGConcentration of Laquinimod in aqueous humor and vitreous samples of human participants
Assessment of concentration of Laquinimod in aqueous humor and vitreous samples of human by biolanalysis in specialized lab participants on Day 14 of Laquinimod eye-drop administration.
Time frame: After 2 weeks of study drug administration
Concentration of Laquinimod in plasma of human participants
Assessment of concentration of Laquinimod in plasma of human participants on Day 14 of Laquinimod in specialized lab eye-drop administration. participants on Day 14 of Laquinimod eye-drop administration.
Time frame: After 2 weeks of study drug administration
Safety Assessment
Any Adverse events: ocular and non-ocular at Post operative Day 1 and Post operative Day 8 compared to baseline.
Time frame: Baseline to end of Study at 22-30days
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