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Topical Infliximab in Autoimmune Eyes With Keratoprosthesis

NCT02126020 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-04-07

No results posted yet for this study

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.

Conditions

  • Stevens-Johnson Syndrome
  • Toxic Epidermal Necrolysis (Lyell) Syndrome
  • Mucous Membrane Pemphigoid

Interventions

DRUG

topical infliximab

topical infliximab administered QID for 3 months followed by BID for 9 months

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    collaborator OTHER

  • Fonds de recherche en ophtalmologie de l'Université de Montréal

    collaborator OTHER

  • James Chodosh, MD, MPH

    lead OTHER

Principal Investigators

  • James Chodosh, MD, MPH · Massachusetts Eye and Ear Infirmary

  • Claes H Dohlman, MD, PhD · Massachusetts Eye and Ear Infirmary

  • Mona Harissi-Dagher, MD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-04-03
Completion
2017-04-03

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02126020 on ClinicalTrials.gov