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Eye surgery breakthrough? tiny trial tests humira injection during corneal implant

NCT ID NCT06926478

Disease control Sponsor: Massachusetts Eye and Ear Infirmary Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This early-stage trial will test whether injecting adalimumab (Humira) into the eye during Boston KPro surgery is safe for 8 patients with severe corneal damage. The study focuses on side effects and tolerability, not yet on how well it works. It is for people who have run out of other options for corneal transplants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adalimumab (Humira) injection
What this could lead to
If safe, this could point toward a way to reduce inflammation and improve outcomes after complex corneal implant surgery.
What could go wrong
This is a very early, tiny trial (8 people) focused only on short-term safety. It is not designed to prove the drug works, and unexpected side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 8 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older * Individuals eligible for keratoprosthesis surgery, as determined by standard-of-care eligibility criteria * Patients with poor prognosis for corneal transplantation, severe corneal opacity and/or vascularization * Patients with vision worse than 20/200 in the eligible eye, and contralateral eye with vision less than 20/40 * Patients with intact nasal light projection * Willing and able to comply with study plan for the full duration of the study * Willing and able to sign a written informed consent Exclusion Criteria: * Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-# release assay \[IGRA\] test, such as Quantiferon-gold) * Untreated active hepatitis B or C infection. * Ocular or periocular malignancy and/or infection * Inability to wear contact lens * Pregnancy (positive pregnancy test) or lactating * Participation in another interventional study at the time of screening * Any of the following baseline lab values 1. White blood count \<3500 cells per microliter 2. Platelets \<100,000 per microliter 3. Hematocrit \<30% 4. AST or ALT \>1.5X upper limit normal value * Multiple sclerosis or other demyelinating disease * Severe uncontrolled infection * Moderate to severe heart failure (NYHA class III/IV) * Active malignancy * History of adalimumab intolerance * Pregnancy or lactation * Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures. * As judged by the investigator any patients that are questionable for their suitability in the study

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Conditions

The condition(s) this trial relates to.

ocular cicatricial pemphigoid Pemphigoid, Benign Mucous Membrane Stevens-Johnson syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple graft failure Ocular cicatricial pemphigoid Penetrating keratoplasty Stevens-Johnson syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.