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Anti-TNF-alpha Antibody

Topical Infliximab for Glaucoma

Phase 1 & 2
Recruiting
Led By Marie-Claude Robert, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 80 years
Capable of administering eye medication or access to a caregiver able and willing to administer the eye medication for the patient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will test whether the anti-inflammatory drug infliximab can prevent the occurrence of glaucoma after cornea surgery.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of topical infliximab may include local irritation in the eyes such as redness or discomfort. Since it's an anti-inflammatory drug used systemically for other conditions too, there might be risks of systemic side effects like infection risk increase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I can put in my eye medication or have someone who can do it for me.
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I am having my first corneal transplant surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complications associated to PKP surgery
Complications associated to infliximab use
Secondary outcome measures
Best Corrected Visual Acuity (BCVA)
Epithelial healing time
Incidence of epithelial keratitis
+5 more

Trial Design

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.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteOTHER
561 Previous Clinical Trials
2,785,641 Total Patients Enrolled
Prism Eye InstituteOTHER
3 Previous Clinical Trials
414 Total Patients Enrolled
1 Trials studying Glaucoma
142 Patients Enrolled for Glaucoma
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,587 Total Patients Enrolled
7 Trials studying Glaucoma
420 Patients Enrolled for Glaucoma

Media Library

Topical Infliximab (Anti-TNF-alpha Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT05180994 — Phase 1 & 2
Glaucoma Research Study Groups: Topical infliximab following PKP surgery, No topical infliximab following PKP surgery
Glaucoma Clinical Trial 2023: Topical Infliximab Highlights & Side Effects. Trial Name: NCT05180994 — Phase 1 & 2
Topical Infliximab (Anti-TNF-alpha Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05180994 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What prerequisites must a participant meet to be eligible for this clinical experiment?

"This trial is open to individuals aged 18-80, providing they have been diagnosed with glaucoma. A total of 50 participants are being accepted into the study."

Answered by AI

Does this research endeavor involve individuals aged 40 and over?

"Eligibility for this medical trial is restricted to adults between 18 and 80 years old. There are also 34 trials for minors as well as 233 trials specifically aimed at seniors over 65."

Answered by AI

What is the current enrollment tally for this clinical experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was first submitted on the 5th of May 2022, is actively recruiting participants. It requires 50 volunteers at 1 medical centre to complete the study."

Answered by AI

To what extent has Topical infliximab been examined in prior experiments?

"Currently, 48 research projects are underway in regards to topical infliximab. Of those studies, 9 of them are at the third stage of development. Although most trials for this medication take place within Houston, Texas there exist 420 other venues running these tests and assessments."

Answered by AI

What objectives are being sought after with this research endeavor?

"This clinical trial will primarily evaluate the potential side effects of infliximab over a six month period. Secondary metrics that will be monitored include Best Corrected Visual Acuity (BCVA) using a Snellen chart, incidence of glaucoma development and epithelial healing time from surgery to complete closure."

Answered by AI

Is there an opportunity to become enrolled in this clinical experiment?

"According to the information found on clinicaltrials.gov, this study is presently enrolling participants; with its original post-date being May 1st 2022 and the last time it was updated occurring July 4th of the same year."

Answered by AI

What medical afflictions does Topical infliximab address?

"When a traditional approach fails to alleviate symptoms, Topical infliximab is often utilized. This therapeutic has proven its efficacy in treating psoriasis, ankylosing spondylitis and crohn disease as well."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Topical Infliximab in Eyes With Penetrating Keratoplasty
2022. "Topical Infliximab in Eyes With Penetrating Keratoplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05180994.
~29 spots leftby Mar 2027
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