Topical Infliximab for Glaucoma
Recruiting in Palo Alto (17 mi)
Overseen byMarie-Claude Robert, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Must not be taking: Anti-TNF-α, Anti-inflammatory biologics
Disqualifiers: Diabetes, Heart failure, Malignancy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Penetrating keratoplasty is a cornea surgery involving several inflammatory complications, of which the most important is glaucoma. Researchers wish to determine whether it is safe to administer infliximab (an anti-inflammatory drug) eye drops after surgery, and whether this eye drop could prevent the occurrence of glaucoma.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used anti-TNF-α medication or other anti-inflammatory biologics before.
Is topical infliximab safe for humans?
Infliximab has been used safely in humans for conditions like inflammatory bowel disease and rheumatoid arthritis, but it can cause some side effects like infusion reactions (headache, fever, chills) and infections. While these side effects are generally manageable, the safety of topical infliximab specifically for glaucoma hasn't been directly studied in humans yet.
12345How is the drug Topical Infliximab unique for treating glaucoma?
Topical Infliximab is unique for treating glaucoma because it is applied directly to the eye, unlike traditional glaucoma treatments that are often oral or injected. It targets tumor necrosis factor alpha (TNF-α), a protein involved in inflammation, which is a novel approach compared to standard treatments that typically focus on reducing eye pressure.
16789Eligibility Criteria
This trial is for adults aged 18-80 undergoing their first corneal transplant surgery who can consent and manage eye medication (or have someone to help). It's not for those with active eye infections, past transplants, severe glaucoma or macular disease, systemic infections, recent cancer, demyelinating diseases, diabetes or heart failure (NYHA class III/IV), pregnant/breastfeeding women, infliximab allergies, abnormal blood counts or liver tests.Inclusion Criteria
I am between 18 and 80 years old.
I can put in my eye medication or have someone who can do it for me.
I am having my first corneal transplant surgery.
+1 more
Exclusion Criteria
Significant anomaly of complete blood count or hepatic enzymes
I have had a corneal transplant in the past.
I currently have an eye infection.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive topical infliximab 10mg/ml eye drops four times per day for 3 months
3 months
Regular visits for monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 months
Regular visits for monitoring
Participant Groups
The study aims to test if using infliximab eye drops after corneal transplant surgery is safe and can prevent glaucoma. Participants will either receive the topical infliximab drops or no treatment as a comparison. The main focus is on safety and effectiveness in preventing inflammation that could lead to glaucoma.
2Treatment groups
Experimental Treatment
Active Control
Group I: Topical infliximab following PKP surgeryExperimental Treatment1 Intervention
Additionally to standard post-operative regimen, patients who will be undergoing their first PKP surgery and who meet all inclusion and no exclusion criteria will be included in the experimental group. These patients will administer topical infliximab four times per day for 3 months.
Group II: No topical infliximab following PKP surgeryActive Control1 Intervention
Patients who will be undergoing their first PKP surgery, but who are not qualified to receive infliximab or who refuse to receive infliximab, will be included in the control group. These patients will only administer the standard post-operative regimen following their PKP surgery and will not administer topical infliximab. They will be followed with the same follow-up schedule, questionnaires, examinations and non-invasive tests (excluding lab work) as patients in the interventional group.
Topical Infliximab is already approved in United States, European Union, Japan for the following indications:
🇺🇸 Approved in United States as Remicade for:
- Rheumatoid arthritis
- Adult and pediatric Crohn’s disease
- Ankylosing spondylitis
- Psoriatic arthritis
- Plaque psoriasis
- Adult and pediatric ulcerative colitis
🇪🇺 Approved in European Union as Remicade for:
- Rheumatoid arthritis
- Crohn’s disease
- Ankylosing spondylitis
- Psoriatic arthritis
- Plaque psoriasis
- Ulcerative colitis
🇯🇵 Approved in Japan as Remicade for:
- Ocular Behçet’s disease
- Rheumatoid arthritis
- Crohn’s disease
- Ankylosing spondylitis
- Psoriatic arthritis
- Plaque psoriasis
- Ulcerative colitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centre Hospitalier de l'Université de MontréalMontréal, Canada
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Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
Ottawa Hospital Research InstituteCollaborator
Prism Eye InstituteCollaborator
Fonds de recherche en ophtalmologie de l'Université de MontréalCollaborator
Maisonneuve-Rosemont HospitalCollaborator
Niagara Health SystemCollaborator
References
A pilot study on ocular safety of intravitreal infliximab in a rabbit model. [2015]To determine whether infliximab may be used safely as an intraocular drug, the ocular safety of intravitreal infliximab in rabbits was studied by clinical examination, electroretinography (ERG), and histology in rabbits.
A decade of infliximab: The Austrian evidence based consensus on the safe use of infliximab in inflammatory bowel disease. [2021]Infliximab (IFX) has tremendously enriched the therapy of inflammatory bowel diseases (IBD) and other immune mediated diseases. Although the efficacy of IFX was undoubtedly proven during the last decade numerous publications have also caused various safety concerns. To summarize the immense information concerning adverse events and safety issues the Austrian Society of Gastroenterology and Hepatology launched this evidence based consensus on the safe use of IFX which covers the following topics: infusion reactions and immunogenicity, skin reactions, opportunistic infections (including tuberculosis), non-opportunistic infections (bacterial and viral), vaccination, neurological complications, hepatotoxicity, congestive heart failure, haematological side effects, intestinal strictures, stenosis and bowel obstruction (SSO), concomitant medication, malignancy and lymphoma, IFX in the elderly and the young, mortality, fertility, pregnancy and breast feeding. To make the vast amount of information practicable for routine application the consensus was finally condensed into a checklist for a safe use of IFX which consists of two parts: issues to be addressed prior to anti-TNF therapy and issues to be addressed during maintenance. Both parts are further divided into obligatory and facultative items.
Infliximab in pediatric rheumatology patients: a retrospective analysis of infusion reactions and severe adverse events during 2246 infusions over 12 years. [2015]To describe infusion reactions (IR) and severe adverse events (SAE) associated with infliximab (IFX) in pediatric patients with rheumatologic and ocular inflammatory diseases in a real-world setting.
Long term safety of infliximab. [2019]Infliximab is a chimeric anti-tumour necrosis factor-alpha monoclonal antibody that has been studied for the treatment of Crohn's disease and rheumatoid arthritis. In several placebo controlled, randomized clinical trials and open trials, 771 patients have been given infliximab (a further 192 received placebo). Follow-up for safety has included the time of study (12 weeks after the last infusion), plus three additional years. Acute infusion reactions (headache, fever, chills, urticaria, chest pain) were seen in 17% of patients receiving infliximab compared with 7% of those receiving placebo. While infections were reported more frequently overall in the patients given infliximab (26% over 27 weeks of follow-up versus 16% of placebo-treated patients over 20 weeks of follow-up), there was no increased risk of serious infections. There was no difference in the overall mortality rate between the groups. While low titres of autoantibodies developed in less than 10% of patients, drug-induced lupus was seen in less than 1%, with these cases resolving upon discontinuation of the drug. Overall, infliximab showed an acceptable safety profile.
P013 Resolution of Infliximab Associated Infusion Hypersensitivity After Switching to Biosimilar Infliximab-dyyb. [2023]Background: Administration of infliximab for the treatment of inflammatory bowel disease has a well-recognized risk of infusion-related (IR) adverse events. The recent introduction of the biosimilar infliximab-dyyb (Inflectra®) has been shown to have similar efficacy with comparable safety profile when compared to infliximab; however, although the active ingredients are similar, the inactive ingredients are different. We present a case of a 26-year-old female with ulcerative colitis who had resolution of her IR hypersensitivity when switched from infliximab to infliximab-dyyb.
INFLIXIMAB and ADALIMUMAB in Uveitic Macular Edema. [2018]To compare the efficacy of infliximab and adalimumab in patients with refractory uveitis-related macular edema (ME).
Anti-tumor necrosis factor alpha for retinal diseases: current knowledge and future concepts. [2021]Tumor necrosis factor alpha (TNF-α) is a pro-inflammatory cytokine produced by macrophages and T-cells. It plays an important role both in inflammation and apoptosis. In the eye, TNF-α appears to have a role in the pathogenesis of inflammatory, edematous, neovascular and neurodegenerative disorders. Several TNF-blocking drugs have been developed and approved, and are in clinical use for inflammatory diseases such as rheumatoid arthritis, psoriasis and ankylosing spondylitis. TNF-α blockers are widely used in ophthalmology as an off-label alternative to "traditional" immunosuppressive and immune-modulatory treatments in noninfectious uveitis. Preliminary studies suggest a positive effect of intravenously administered TNF-α blockers, mainly infliximab, for treating refractory diabetic macular edema and neovascular age-related macular degeneration. Unfortunately, much of the current data raises considerable safety concerns for intravitreal use of TNF-α inhibitors, in particular, intraocular inflammatory responses have been reported after intravitreal injection of infliximab. Results of dose-finding studies and humanized antibody or antibody fragments (e.g. adalimumab) are anticipated in the coming years; these will shed light on potential benefits and risks of local and systemic TNF-α blockers used for treatment of diseases of the retina and choroid.
The use of infliximab in ocular inflammation. [2015]Experience with anti-tumour necrosis factor alpha medications in ophthalmology has been mainly in the treatment of resistant uveitis and scleritis. There have been a few case reports and one case series detailing the use of infliximab in the treatment of orbital inflammatory disease, but there is still limited experience with these agents in a variety of orbital inflammatory conditions. We describe successful suppression of inflammation with infliximab in the Idiopathic orbital inflammation, thyroid associated orbital inflammation and chronic relapsing inflammatory optic neuropathy.
Comparative Study of Infliximab Versus Adalimumab in Refractory Uveitis due to Behçet's Disease: National Multicenter Study of 177 Cases. [2020]To compare the efficacy of infliximab (IFX) versus adalimumab (ADA) as a first-line biologic drug over 1 year of treatment in a large series of patients with refractory uveitis due to Behçet's disease (BD).