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Topical Infliximab for Sterile Corneal Melt

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ClinicalTrials.gov Identifier: NCT02987686
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Fonds de recherche en ophtalmologie de l'Université de Montréal (FROUM)
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:

Corneal melt is a complication that could affect very ill eyes and lead to the thinning of the cornea (the clear window covering of the eyes). This thinning can lead to severe consequences such as the leakage of the liquid inside the eye (ocular perforation), or even blindness. Corneal melt can be caused by certain infections or as a sterile process. This project only includes patients with a sterile corneal melt (without an infection) caused by diseases such as rosacea, Sjogren's syndrome, rheumatoid arthritis, Crohn's disease, Stevens Johnson syndrome, as well as toxic epidermal necrolysis or mucous membrane pemphigoid.

Infliximab is an antibody against tumour necrosis factor alpha and has been used to treat or prevent corneal melt in certain patients with inflammatory of auto-immune disease. In this situation, infliximab was used intravenous (using veins) in order to treat the whole body.

This study's hypothesis is that infliximab can safely be used as eye drops for the treatment of sterile corneal melt.


Condition or disease Intervention/treatment Phase
Sterile Corneal Melt Drug: Topical Infliximab Phase 1

Detailed Description:

This is an unmasked, prospective, single-center trial of twelve patients with sterile corneal melt and an underlying auto-immune or inflammatory disease, such as rosacea, Sjogren's syndrome, rheumatoid arthritis, Crohn's disease, Stevens Johnson syndrome, as well as toxic epidermal necrolysis or mucous membrane pemphigoid.

The aim of this phase I study is to evaluate the safety and tolerability of topical infliximab 10mg/ml eye drops for the treatment of corneal melt. As such, six (6) subjects will be recruited in the experimental treatment study and six (6) subjects will be enrolled in the parallel observational study. Indeed, candidates having all inclusion criteria but one exclusion criteria (which are contraindication to infliximab use), will be recruited in the observational study, will receive the standard treatment without infliximab.

During the treatment period, subjects in the therapeutic study will receive topical infliximab 10mg/ml four (4) times per day for four (4) weeks. In order to determine the safety profile, potential side effects as well as the course of the disease, subjects will be monitored while on the study medication as well as for 8 weeks following discontinuation of the drug. The ophthalmological follow-up will be identical in the two groups. However, only subjects enrolled in the experimental treatment study will receive additional laboratory tests. The total study duration for each patient will be 12 weeks.

In terms of statistical analysis, the investigators will focus on describing the outcome measured in the study. For instance, the investigators will describe the number and proportion of side effects, the number of patients with a quiescent corneal melt at 4 weeks and the patients who required a tectonic surgery at 12 weeks post-treatment. The investigators will report the average and standard of deviation of the OSDI score, the epithelial deficit surface as well as the minimal corneal thickness. Moreover, the investigators will perform exploratory statistical analysis in order to study the disease course of each subject and comparing the addition of infliximab to the standard.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Infliximab for the Treatment of Sterile Corneal Melt
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: Topical Infliximab
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.
Drug: Topical Infliximab
Aside from the standard treatment, patients will receive topical infliximab ( 10mg/ml) four (4) time per day for four (4) weeks.
Other Name: Remicade

No Intervention: Observational group
Patients with all inclusive criteria and one exclusive criteria will receive the standard treatment, without topical infliximab.



Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 12 weeks ]
    Number and type of adverse events

  2. Percentage of patients finishing 4 weeks of infliximab use [ Time Frame: 4 weeks ]
    Percentage of patients finishing 4 weeks of infliximab use


Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 4 and 12 weeks ]
    Visual Acuity is measured using a Snellen chart

  2. Ocular surface symptoms as assessed by ocular disease index score [ Time Frame: 4 and 12 weeks ]
    Ocular surface symptoms as assessed by ocular disease index score

  3. Conjunctival hyperemia using a slit-lamp photographs [ Time Frame: 4 and 12 weeks ]
    Conjunctival hyperemia using a slit-lamp photographs

  4. Corneal thickness as measured by anterior segment optical coherence tomography [ Time Frame: 4 weeks ]
    Corneal thickness as measured by anterior segment optical coherence tomography

  5. Surface area of the corneal melt using a slit-lamp photographs [ Time Frame: 4 weeks ]
    Surface area of the corneal melt using a slit-lamp photographs

  6. Quiescent corneal state [ Time Frame: 4 weeks ]
    Percentage of eyes presenting a quiescent corneal state at 4 weeks

  7. Eyes requiring tectonic surgery [ Time Frame: 12 weeks ]
    Percentage of eyes requiring tectonic surgery at 12 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 80 years;
  • Any degree of active sterile corneal melting , as documented by slit-lamp examination, showing an epithelial defect and stromal thinning;
  • Negative work-up for local and systemic infectious causes
  • Negative corneal cultures (may show growth of common contaminants)
  • Capable of providing informed consent;
  • Capable of administering eye drops either themselves or through a caregiver.

Exclusion Criteria:

  • Any active ocular or systemic infection including active or latent tuberculosis, histoplasmosis, coccidiomycosis, cytomegalovirus, pneumocystosis, aspergillosis, or hepatitis B.
  • History of neoplasia diagnosed within the last 5 years
  • Demyelinating disease
  • Diabetes
  • Congestive heart failure
  • Significant anomalies on complete blood count, creatinine or hepatic enzymes
  • Pregnancy or breast feeding
  • Allergy to infliximab or to the drug vehicle (Refresh liquigel)
  • Past or present use of anti-TNF-α medications or human interleukin-1 receptor antagonist (anakinra, IL-1Ra)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987686


Contacts
Contact: Marie-Claude Robert, MD 514 890-8000 ext 11550 marie-claude.robert.2@umontreal.ca
Contact: Marie-Catherine Tessier 514 890-8000 ext 11550 marie-catherine.tessier.chum@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2X3E4
Contact: Marie-Catherine Tessier    5148908000 ext 11550      
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Fonds de recherche en ophtalmologie de l'Université de Montréal (FROUM)
Investigators
Principal Investigator: Marie-Claude Robert, MD Centre hospitalier de l'Université de Montréal (CHUM)

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02987686     History of Changes
Other Study ID Numbers: CE 16.221.
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Topical Infliximab
Cornea
Keratolysis

Additional relevant MeSH terms:
Infertility
Corneal Ulcer
Genital Diseases, Male
Genital Diseases, Female
Eye Infections
Infection
Keratitis
Corneal Diseases
Eye Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents