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Stevens-Johnson SyndromePhase 1/2NCT02126020

Topical Infliximab in Autoimmune Eyes With Keratoprosthesis

A Phase 1/2 study testing topical infliximab in people with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (Lyell) Syndrome, run by James Chodosh, MD, MPH at 2 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
topical infliximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesin 2 countries
Study dates
Nov 2014to 3 Apr 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 20Show fewer
  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts, 02114

Other trials in United States

Canada1 site

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2L 4M1

Other trials in Canada

About this study

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.

Read the 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.

Being tested
topical infliximab
Keywords
Keratoprosthesis, corneal melt, keratolysis, Tumor necrosis factor alpha, infliximab, matrix metalloproteinase
Medical subject headings
Stevens-Johnson Syndrome, Syndrome, Pemphigoid, Benign Mucous Membrane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • topical infliximabDrug

    Also called Remicade

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

Study groups in NCT02126020
Study groupRoleWhat they receive
topical infliximabExperimentaltopical infliximab 10 mg/mL QID x 3 months followed by BID x 9 months
Receives: Drug: topical infliximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerability

    Percentage of patients finishing 12 months of topical infliximab use

    Measured: 1 year

  2. Adverse events

    Number and type of adverse events

    Measured: 2 years

  3. rate of corneal melting

    rate of corneal melting or ulceration during infliximab prophylaxis (12 months) and after the drug is stopped (following 12 months)

    Measured: 2 years

  4. KPro retention

    Percentage of retained KPros at 2 years

    Measured: 2 years

Secondary outcomes (5)

  1. Visual acuity

    Measured: 2 years

  2. Ocular surface symptoms

    Ocular surface symptoms as assessed by ocular surface disease index score

    Measured: 2 years

  3. Ocular surface inflammation

    Ocular surface inflammation using slit-lamp photographs and the ocular redness index (ORI)

    Measured: 2 years

  4. tear matrix metalloproteinase (MMP)

    Levels and activity of MMPs, myeloperoxidase and tissue inhibitor of MMP-1

    Measured: 2 years

  5. graft thickness

    Corneal carrier graft thickness as measured by anterior segment optical coherence tomography before, during and after treatment with infliximab

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion3 Apr 2017
  4. Study completion3 Apr 2017 (estimated)

Why it stopped: No patients met eligibility criteria. The study has been closed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02126020
Sponsor's protocol ID
MEEI 13-110H
Other IDs
IND 122719
Status last verified
Apr 2017
First submitted
27 Apr 2014
Last updated
7 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing topical infliximab in people with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (Lyell) Syndrome, run by James Chodosh, MD, MPH at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02126020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.

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