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Trial record 2 of 3 for:    "Cicatricial Pemphigoid" | "Antirheumatic Agents"

Topical Infliximab in Autoimmune Eyes With Keratoprosthesis

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ClinicalTrials.gov Identifier: NCT02126020
Recruitment Status : Withdrawn (No patients met eligibility criteria. The study has been closed.)
First Posted : April 29, 2014
Last Update Posted : April 7, 2017
Sponsor:
Collaborators:
Massachusetts Eye and Ear Infirmary
Fonds de recherche en ophtalmologie de l'Université de Montréal
Information provided by (Responsible Party):
James Chodosh, MD, MPH, Massachusetts Eye and Ear Infirmary

Tracking Information
First Submitted Date  ICMJE April 27, 2014
First Posted Date  ICMJE April 29, 2014
Last Update Posted Date April 7, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date April 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2014)
  • Tolerability [ Time Frame: 1 year ]
    Percentage of patients finishing 12 months of topical infliximab use
  • Adverse events [ Time Frame: 2 years ]
    Number and type of adverse events
  • rate of corneal melting [ Time Frame: 2 years ]
    rate of corneal melting or ulceration during infliximab prophylaxis (12 months) and after the drug is stopped (following 12 months)
  • KPro retention [ Time Frame: 2 years ]
    Percentage of retained KPros at 2 years
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02126020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2014)
  • Visual acuity [ Time Frame: 2 years ]
  • Ocular surface symptoms [ Time Frame: 2 years ]
    Ocular surface symptoms as assessed by ocular surface disease index score
  • Ocular surface inflammation [ Time Frame: 2 years ]
    Ocular surface inflammation using slit-lamp photographs and the ocular redness index (ORI)
  • tear matrix metalloproteinase (MMP) [ Time Frame: 2 years ]
    Levels and activity of MMPs, myeloperoxidase and tissue inhibitor of MMP-1
  • graft thickness [ Time Frame: 2 years ]
    Corneal carrier graft thickness as measured by anterior segment optical coherence tomography before, during and after treatment with infliximab
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Infliximab in Autoimmune Eyes With Keratoprosthesis
Official Title  ICMJE Topical Infliximab in Autoimmune Eyes With Keratoprosthesis
Brief Summary

The Boston Keratoprosthesis type I (KPro) is a prosthetic cornea used to treat several causes of corneal blindness. Some categories of patients, including those with auto-immune diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis syndrome and mucous membrane pemphigoid, have a higher risk of failure for the KPro. Because of chronic inflammation, the cornea supporting the KPro may melt, leading to a higher risk of infection, loss of the KPro and loss of the eye.

Infliximab is an antibody against tumor necrosis factor alpha and is used intravenously to control inflammation in several diseases. It has been used in some cases of corneal melting with significant success.

This study's hypothesis is that infliximab can be successfully used as an eye drop (instead of the usual administration through veins) and that its regular use may prevent melt in eyes with a Boston Keratoprosthesis type I and underlying auto-immune disease.

Detailed Description

This is an unmasked, prospective, multicenter clinical trial of four patients that are candidates for a Boston Keratoprosthesis or have had prior KPro surgery and have a diagnosis of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis syndrome (TENS) or mucous membrane pemphigoid (MMP). Only one eye per patient will be considered for inclusion.

This is a phase I/II study to evaluate the safety and tolerance of topical infliximab 10 mg/mL eye drops. Research subjects will be required to administer infliximab eye drops four times per day for three months followed by twice daily administration for nine months. The subjects will be monitored while on the study medication as well as for one year following discontinuation of the drug. The total study duration for each patient will be two years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Stevens-Johnson Syndrome
  • Toxic Epidermal Necrolysis (Lyell) Syndrome
  • Mucous Membrane Pemphigoid
Intervention  ICMJE Drug: topical infliximab
topical infliximab administered QID for 3 months followed by BID for 9 months
Other Name: Remicade
Study Arms  ICMJE Experimental: topical infliximab
topical infliximab 10 mg/mL QID x 3 months followed by BID x 9 months
Intervention: Drug: topical infliximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 5, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2014)
4
Estimated Study Completion Date  ICMJE April 3, 2017
Actual Primary Completion Date April 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 18 and 80 years
  • Able to provide informed consent
  • Underlying diagnosis of SJS, TENS, or MMP
  • Implantation of a Boston KPro type I
  • Able to administer eye medications or have a care giver able and willing to do same
  • Negative tuberculosis screening

Exclusion Criteria:

  • Active or recurrent ocular or systemic infection

    • Chest radiography, QuantiFERON-TB Gold or purified protein derivative (PPD) evidence of active or latent tuberculosis infection
    • Indeterminate initial and repeat QuantiFERON-TB Gold results
    • History of Bacille Calmette-Guerin (BCG) vaccination within twelve months of screening
    • History of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
    • Chest radiograph within three months prior to the first administration of the study drug that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis.
    • History of a nontuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, pneumocystosis, aspergillosis) within six months prior to screening
    • history of hepatitis B virus
    • Methicillin resistant Staphylococcus aureus (MRSA) or vancomycin resistant enterococcus (VRE) infection
  • Malignancy diagnosed in the last five years
  • Demyelinating disease
  • History or current diagnosis of diabetes mellitus (controlled and uncontrolled)
  • Heart failure (New York Heart Association class III or IV)
  • Pregnancy or breast-feeding
  • Scheduled to receive a live vaccine at any time point during study participation
  • Allergy to infliximab or any of the compounds in its topical formulation or any chemically-related medication
  • Prior or current use of systemic anti-tumor necrosis alpha-α medications or currently receiving treatments of Kineret (Anakinra)
  • KPro designs with less than 16 holes in the back plate (to avoid the confounder of corneal nutrition)
  • Inability to comply with the instillation of additional drops
  • Unable to attend postoperative visits or administer medications, or no care giver available and willing to assist with same
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02126020
Other Study ID Numbers  ICMJE MEEI 13-110H
IND 122719 ( Other Identifier: FDA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party James Chodosh, MD, MPH, Massachusetts Eye and Ear Infirmary
Study Sponsor  ICMJE James Chodosh, MD, MPH
Collaborators  ICMJE
  • Massachusetts Eye and Ear Infirmary
  • Fonds de recherche en ophtalmologie de l'Université de Montréal
Investigators  ICMJE
Principal Investigator: James Chodosh, MD, MPH Massachusetts Eye and Ear Infirmary
Study Chair: Claes H Dohlman, MD, PhD Massachusetts Eye and Ear Infirmary
Study Chair: Mona Harissi-Dagher, MD Centre hospitalier de l'Université de Montréal (CHUM)
PRS Account Massachusetts Eye and Ear Infirmary
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP