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Monoclonal Antibodies

Topical Infliximab for Corneal Melt

Phase 1

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 18 to 80 years

Capable of administering eye drops either themselves or through a caregiver

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 and 12 weeks

Awards & highlights

Study Summary

This trial is testing whether infliximab can safely be used as eye drops to treat a serious complication that could lead to blindness.

Who is the study for?

This trial is for adults aged 18-80 with active sterile corneal melting, which isn't caused by an infection. Participants must be able to give consent and use eye drops themselves or with help. They can't have used certain immune system drugs, have a recent cancer history, heart failure, demyelinating disease, diabetes, be pregnant/breastfeeding or allergic to the study drug.Check my eligibility

What is being tested?

The trial tests if Infliximab eye drops are safe for treating sterile corneal melt—a serious condition where the clear front part of the eye thins without infection. The hypothesis is that applying Infliximab directly to the eyes might prevent damage and preserve vision.See study design

What are the potential side effects?

While not specified here, typical side effects of topical Infliximab may include irritation at application site, increased risk of local infections in the eye area due to immune suppression and potential systemic absorption leading to broader immunosuppressive effects.

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.

Select...

I can put in my eye drops or have someone who can do it for me.

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I have a condition where my cornea is thinning and has an open sore, confirmed by an eye exam.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Percentage of patients finishing 4 weeks of infliximab use

Secondary outcome measures

Conjunctival hyperemia using a slit-lamp photographs

Corneal thickness as measured by anterior segment optical coherence tomography

Eyes requiring tectonic surgery

+4 more

Side effects data

From 2020 Phase 4 trial • 42 Patients • NCT03006393

52%

Laceration

38%

Headache

24%

Bruises

19%

Sore throat

14%

Muscle tension

10%

Change in urination

10%

Heartburn

10%

Fatigue

10%

Nausea

10%

Dizziness

10%

Itchiness

Menstruation

Pain in joints

Migraine

Stomach ache

Syncope

Chest pain

Swelling

Bloody stool

Pain in leg

Allergies

Change in blood pressure

Vertigo

Change in appetite

Numbness

Motor vehicle accident

100%

80%

60%

40%

20%

Study treatment Arm

Infliximab

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Topical InfliximabExperimental Treatment1 Intervention

Additionally to standard treatment, patients with all inclusive criteria and none exclusive criteria will be included in the therapeutic group and will receive topical infliximab QID for 4 weeks.

Group II: Observational groupActive Control1 Intervention

Patients with all inclusive criteria and one exclusive criteria will receive the standard treatment, without topical infliximab.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,625 Total Patients Enrolled

Fonds de recherche en ophtalmologie de l'Université de MontréalOTHER

5 Previous Clinical Trials

147 Total Patients Enrolled

Marie-Claude Robert, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)

2 Previous Clinical Trials

90 Total Patients Enrolled

Media Library

Topical Infliximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02987686 — Phase 1

Corneal Melt Research Study Groups: Topical Infliximab, Observational group

Corneal Melt Clinical Trial 2023: Topical Infliximab Highlights & Side Effects. Trial Name: NCT02987686 — Phase 1

Topical Infliximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02987686 — Phase 1

Frequently Asked Questions

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

What health conditions is Topical Infliximab commonly employed to address?

"Topical Infliximab can be employed to alleviate symptoms of inadequate response to traditional therapies, psoriasis, and ankylosing spondylitis."

Answered by AI

Is it possible to register for this medical experiment?

"To be suitable for this trial, participants must meet the following prerequisites: Be between 18 and 80 years old; possess an active corneal ulcer confirmed by slit-lamp examination; have negative results in both their local and systemic infectious workups; have no growth of contaminants seen on a corneal culture sample. In addition, they must demonstrate the ability to either self-administer eye drops or accept assistance from a caregiver when doing so. Furthermore, all potential enrollees are required to provide informed consent prior to being admitted into the study."

Answered by AI

Are enrollment opportunities currently open for this experiment?

"Affirmative. Per clinicaltrials.gov, this medical investigation is still recruiting participants since its initial posting on September 6th 2017 and most recent amendment on November 18th 2021. 12 individuals are needed to be enrolled at one experimental site."

Answered by AI

Is the age requirement for this medical trial restricted to those younger than 60?

"The parameters for enrollment in this trial dictate that patients must be between 18 and 80 years old."

Answered by AI

Are there any other studies that have investigated the efficacy of Topical Infliximab?

"Currently, 48 trials for topical infliximab are ongoing. Of those active studies, 9 have entered Phase 3 of the clinical trial process. Despite being primarily based in Houston, Texas, there is an expansive network of 420 sites running investigations into this medication."

Answered by AI

What potential perils might be associated with Topical Infliximab?

"Due to the limited clinical data available, our team at Power gave topical Infliximab a score of 1 for safety on an established scale from 1 to 3."

Answered by AI

What are the key goals of this research endeavor?

"This trial, with a duration of 3 months, seeks to quantify the rate of patients who complete 4 weeks of infliximab therapy. Additional goals include evaluating quiescent corneal state by percentage at week 4, measuring corneal thickness using anterior segment optical coherence tomography and determining surface area of the corneal melt via slit-lamp photographs."

Answered by AI

What is the total recruitment number for this trial?

"Affirmative, clinicaltrials.gov contains information that this study is presently enrolling volunteers. It was initially published on September 6th 2017 and its details were most recently updated on November 18th 2021 and it is accepting up to 12 participants from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Topical Infliximab for Sterile Corneal Melt

2017. "Topical Infliximab for Sterile Corneal Melt". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02987686.

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