Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Quan Dong Nguyen
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications before and during the study. Specifically, you must not use any topical cyclosporine, corticosteroid, or other specified eye medications in the study eye within 14 days of enrollment. Additionally, you must avoid medications that are strong or moderate inhibitors or inducers of CYP3A4 within 2 weeks of the baseline visit and during the study.
Is Laquinimod generally safe for humans?
Laquinimod has been studied for multiple sclerosis and was found to be safe and well-tolerated in early human trials, with a better side effect profile compared to a similar drug, roquinimex.
12345How is the drug Laquinimod different from other treatments for uveitis?
Laquinimod eye drops for uveitis are unique because they offer a non-steroidal, potentially less invasive treatment option compared to traditional therapies like corticosteroids or immunosuppressive agents, which often have significant side effects. Unlike systemic treatments, Laquinimod is administered directly to the eye, which may reduce systemic exposure and associated risks.
678910Eligibility Criteria
The LION Study is for adults over 18 who can follow study instructions and consent to participate. It's suitable for non-pregnant, non-lactating women who are post-menopausal or sterilized. Participants must be scheduled for specific eye surgeries (PPV or diagnostic vitrectomy) and have normal intraocular pressure.Participant Groups
This trial tests Laquinimod eye drops' safety and how well they're tolerated when used daily for two weeks. Researchers also want to see how the drug spreads in the eyes of participants undergoing certain eye surgeries.
5Treatment groups
Experimental Treatment
Group I: Stage 2 Comparison Group BExperimental Treatment1 Intervention
(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops in the study eye for 14 days before the surgery. Frequency to be decided at the end of stage 1.
Group II: Stage 2 Comparison Group AExperimental Treatment1 Intervention
(3 to 6 participants): Participants will receive a dose of Laquinimod eye drops in the study eye for 14 days before the surgery. Frequency to be decided at the end of stage 1.
Group III: Group 3Experimental Treatment1 Intervention
(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops three times a day(1.8 mg per day) for 14 days before the surgery.
Group IV: Group 2Experimental Treatment1 Intervention
(3 to 6 participants): Participants will receive a dose of Laquinimod as 2 drops twice a day (1.2mg per day) in the study eye for 14 days before the surgery
Group V: Group 1Experimental Treatment1 Intervention
(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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Spencer Center for Vision Research at the Byers Eye InstitutePalo Alto, CA
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Who is running the clinical trial?
Quan Dong NguyenLead Sponsor
Global Ophthalmic Research Center (GORC)Collaborator
References
Incidence of uveitis and macular edema among patients taking fingolimod 0.5 mg for multiple sclerosis. [2020]Patients with multiple sclerosis (MS) have a higher incidence of uveitis compared with the general population. Fingolimod, a first line disease modifying drug used in multiple sclerosis, may cause macular edema and thus requires ophthalmic examination. However, murine models and anecdotal reports suggest fingolimod may reduce the incidence of uveitis.
Laquinimod protects the optic nerve and retina in an experimental autoimmune encephalomyelitis model. [2019]The oral immunomodulatory agent laquinimod is currently evaluated for multiple sclerosis (MS) treatment. Phase II and III studies demonstrated a reduction of degenerative processes. In addition to anti-inflammatory effects, laquinimod might have neuroprotective properties, but its impact on the visual system, which is often affected by MS, is unknown. The aim of our study was to investigate potential protective effects of laquinimod on the optic nerve and retina in an experimental autoimmune encephalomyelitis (EAE) model.
Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. [2022]To report outcomes of ophthalmic evaluations in clinical studies of patients receiving fingolimod (Gilenya; Novartis Pharma AG, Basel, Switzerland) for multiple sclerosis (MS).
Laquinimod (ABR-215062) for the treatment of relapsing multiple sclerosis. [2015]Laquinimod (ABR-215062) is an oral immunomodulatory agent developed for the treatment of relapsing multiple sclerosis (MS). Laquinimod is a derivative of the drug roquinimex, but lacks the unacceptable side effect profile of this drug which was documented in previous MS trials. Preclinical studies in experimental models of MS, both of autoimmune neuroinflammation and of toxin induced demyelination show a multitude of immunomodulatory and anti-inflammatory effects, including some that are effective directly in the central nervous system. Phase I study results confirmed the safety and tolerability of laquinimod, and phase II and III studies provide a picture of a consistent albeit moderate effect on relapse rate and new lesion development on magnetic resonance imaging combined with a stronger effect on sustained progression and brain atrophy. These findings make laquinimod a potentially useful future treatment of MS.
[EBM analysis: classic DMARDs (disease-modifying antirheumatic drugs) and immunosuppressants in arthritis and uveitis]. [2015]The best experience in the use of DMARDs/immunosuppressive drugs for treatment of juvenile idiopathic arthritis (JIA) and JIA-associated uveitis has been obtained with MTX. Controlled studies on the treatment of uveitis in JIA, however, are still lacking; this is also true for other DMARDs/immunosuppressive drugs. Thus, the grading of the evidence level for these substances only reaches evidence level III (expert opinion, clinical experience or descriptive studies). For the treatment of uveitis in JIA the utility of MTX in comparison to the new biological substance classes (e. g., tumor necrosis factor-alpha, blockers, interleukin-1 receptor antagonist) will have to be examined. Experience with Mycophenolate mofetil (MMF) in JIA uveitis is limited to single cases. According to data from a retrospective analysis cyclosporin A (CsA) appears to have a limited efficacy in JIA uveitis. The results with azathioprine are not consistent. Controlled studies which led to the approval of drugs for JIA are also mandatory for uveitis to offer the most effective and safe therapy for children.
ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis. [2019]To assess the efficacy and safety of adalimumab on uveitis in patients with early onset, chronic, juvenile idiopathic arthritis (JIA)-associated or idiopathic anterior uveitis and an inadequate response to topical steroids and methotrexate (MTX).
Bilateral 0.19 mg Fluocinolone Acetonide Intravitreal Implant in the Successful Treatment of Juvenile Idiopathic Arthritis-Associated Uveitis and Secondary Macular Oedema: A Case Report and Review of Intravitreal Therapies. [2021]Label="INTRODUCTION" NlmCategory="BACKGROUND">Treatment of juvenile idiopathic arthritis (JIA)-associated uveitis necessitates the use of long-term corticosteroids or immunosuppressive agents, each of which poses their own significant side effect profile. Initial treatment requires intensive topical glucocorticoids, with a step-up approach employing immunosuppressive agents for those cases with poor response or high-risk complications such as macular oedema. To date, there is minimal evidence to support a specific approach to such complicated subgroups. We present the first case to successfully employ the 0.19 mg fluocinolone acetonide implant (ILUVIEN®, Alimera Sciences, Hampshire, UK) as a novel device for prolonged intravitreal administration of disease-modifying agents for patients with JIA complicated by uveitis.
High Efficacy of Methotrexate in Patients with Recurrent Idiopathic Acute Anterior Uveitis: a Prospective Study. [2017]To evaluate prospectively the efficacy of methotrexate (MTX) in the treatment of recurrent idiopathic acute anterior uveitis (RIAAU). Nineteen out of 22 RIAAU patients completed the study (two patients withdrew their consent shortly after study initiation, one patient discontinued after 4 weeks because of the adverse effects). All patients were treated with MTX in a starting dose of 15 mg/week, increased to target dose of 25 mg/week after 4 weeks. In patients taking systemic corticosteroids (CS) the dose was gradually tapered (by 2.5 mg every week) until discontinuation. The mean follow-up period was 3.3 years (19-59 months). Sixteen patients (84 %) remained flare-free on MTX therapy. In the remaining three patients the mean interval between flares increased from 4.8 to 18.3 months. Systemic CS were tapered off in all patients. The number of acute anterior uveitis flares in the whole cohort decreased from 2.12 to 0.11/patient-year (p
Treatment with repeat dexamethasone implants results in long-term disease control in eyes with noninfectious uveitis. [2022]To describe the long-term outcome of eyes with uveitis after repeated treatment with dexamethasone implants (Ozurdex; Allergan, Inc., Irvine, CA).
TNFalpha-blocking agents or conventional immunosuppressive drugs in the therapy of children with uveitis? - an evidence based approach. [2013]Treatment of childhood uveitis associated with juvenile idiopathic arthritis (JIA) is a challenge for both, ophthalmologists and pediatricians. In this study, we use the tools of evidence based medicine (EBM) to analyse studies concerning disease-modifying antirheumatic drugs (DMARD)/ immunosuppressive drugs and tumor necrosis factor alpha (TNFalpha) blocking agents. Most experience among DMARD's/ immunosuppressive drugs has been obtained with methotrexate (MTX) in juvenile idiopathic arthritis. However, controlled studies in uveitis are still missing, so that treatment with MTX and all other immunosuppressive drugs (ciclosporine A, azathioprine, mycophenolate mofetil) only reaches an evidence level III (expert opinion, clinical experience or descriptive study). Studies on TNFalpha-blocking agents reach an evidence level II-III, depending on the substance. In future, MTX will have to be examined in comparison to the new biological substance classes (e.g., tumor necrosis factor-alpha-blockers) for the treatment of uveitis in juvenile idiopathic arthritis. Controlled studies which have led to the approval of drugs for JIA are needed for uveitis in order to have the most effective and safe therapy for children with uveitis, who do not respond to conventional therapy with local and systemic steroids.