Penetrating KeratoplastyPhase 1NCT06926478
Subconjunctival Humira for Boston Keratoprosthesis
A Phase 1 study testing Adalimumab Injection in people with Penetrating Keratoplasty and Multiple Graft Failure, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Penetrating Keratoplasty, Multiple Graft Failure, Ocular Cicatricial Pemphigoid
- What is being tested?
- Adalimumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- Any of the following baseline lab values
- White blood count <3500 cells per microliter
- Platelets <100,000 per microliter
- Hematocrit <30%
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
Michael Cheung, MSc, CCRP, 617-573-6060, MCHEUNG0@MEEI.HARVARD.EDU
Thomas Dohlman, MD
About this study
Official title: Clinical Trial to Evaluate Short-term Safety of Subconjunctival Adalimumab in Combination With Type 1 Boston Keratoprosthesis Implantation
This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.
Read the detailed description
This is a Phase I, Open-label, IND trial for participants undergoing a Boston Keratoprosthesis (KPro) procedure, to receive an injection of adalimumab (Humira), to study the safety and tolerability as well, to study whether there is a decrease to post surgical complications, and symptoms that participants would experience, if they did not receive the injection.
The study will recruit eight (8) participants, who will be monitored for thirty (30) days after the surgery, through eye examination and eye photos.
- Conditions
- Penetrating Keratoplasty, Multiple Graft Failure, Ocular Cicatricial Pemphigoid, Stevens-Johnson Syndrome
- Being tested
- Adalimumab Injection
- Keywords
- Kpro, Boston Kpro, Keratoprosthesis, Type-1 Boston Kpro
- Medical subject headings
- Pemphigoid, Benign Mucous Membrane, Stevens-Johnson Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab InjectionDrug
Also called Humira
10% (4.0mg/0.04ml) dissolved in sterile saline to be injected once during the time of the Boston Keratoprosthesis (Kpro) Surgery.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab (Humira) | Experimental | This arm will receive the study intervention. Receives: Drug: Adalimumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Treatment Related Adverse Events.
To evaluate safety following subconjunctival injection of adalimumab at the time of keratoprosthesis surgery in patients who have corneal problems of such severity that they require keratoprosthesis implantation. The incidence, severity, and duration of adverse events will be assessed and documented. Because the subjects in this study have corneal problems of such severity that they require keratoprosthesis implantation, special attention will be given to adverse events of particular concern, such as microbial keratitis, subconjunctival hemorrhage, subconjunctival inflammation, or retinal necrosis or retinal detachment
Measured: 30 Days
Secondary outcomes (5)
Efficacy of adalimumab Injection though changes in visual acuity.
This efficacy outcome measure will be analyzed though changes of any worsening of the best corrective visual acuity by 15 letters at every study visit.
Measured: 30 Days
Efficacy of adalimumab Injection though changes in Optic Nerve Cup-to-Disk Ratio
This efficacy outcome measure will be analyzed through any changes to the cup-to-disk ratio. A normal ratio is 0.2mm
Measured: Every Two (2) Weeks After Implantation/Injection until Day 30
Efficacy of adalimumab Injection through incidences of Intraocular Inflammation
This efficacy outcome measure will be analyzed though any incidences of intraocular inflammation that occurs post implantation/injection.
Measured: 30 Days
Efficacy of adalimumab Injection through changes in the Ocular Coherence Tomography (OCT) of the Optic Nerves
This efficacy outcome measure will be analyzed though any changes in the retinal nerve fiber layer thickness (nerve edema).
Measured: 30 Days
Efficacy of adalimumab Injection though changes in the ocular coherence tomography (OCT) of the Retina
This efficacy outcome measure will be analyzed though increases in the foveal retinal thicknesses by an increase of more than (>)100um in comparison to the previous study visit(s).
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penetrating KeratoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas H. Dohlman, MD, Massachusetts Eye and Ear Infirmary
- Investigators
- Thomas Dohlman, MD, Principal investigator, Massachusetts Eye and Ear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926478
- Sponsor's protocol ID
- 2025P000846
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate Short-term Safety of Subconjunctival Adalimumab in Combination With Type 1 Boston Keratoprosthesis Implantation
- ClinicalTrials.gov ID
- NCT06926478
- Acronym / sponsor ID
- 2025P000846
- Conditions
- Penetrating Keratoplasty, Multiple Graft Failure, Ocular Cicatricial Pemphigoid, Stevens-Johnson Syndrome
- Keywords
- Kpro, Boston Kpro, Keratoprosthesis, Type-1 Boston Kpro
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.
Detailed description
This is a Phase I, Open-label, IND trial for participants undergoing a Boston Keratoprosthesis (KPro) procedure, to receive an injection of adalimumab (Humira), to study the safety and tolerability as well, to study whether there is a decrease to post surgical complications, and symptoms that participants would experience, if they did not receive the injection.
The study will recruit eight (8) participants, who will be monitored for thirty (30) days after the surgery, through eye examination and eye photos.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab (Humira) | Experimental | Drug: Adalimumab InjectionThis arm will receive the study intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalimumab InjectionAlso: Humira10% (4.0mg/0.04ml) dissolved in sterile saline to be injected once during the time of the Boston Keratoprosthesis (Kpro) Surgery. | Drug | Adalimumab (Humira) |
Primary outcome
Evaluation of Treatment Related Adverse Events.
Time frame: 30 Days
To evaluate safety following subconjunctival injection of adalimumab at the time of keratoprosthesis surgery in patients who have corneal problems of such severity that they require keratoprosthesis implantation. The incidence, severity, and duration of adverse events will be assessed and documented. Because the subjects in this study have corneal problems of such severity that they require keratoprosthesis implantation, special attention will be given to adverse events of particular concern, such as microbial keratitis, subconjunctival hemorrhage, subconjunctival inflammation, or retinal necrosis or retinal detachment
5 secondary outcomes
Efficacy of adalimumab Injection though changes in visual acuity.
Time frame: 30 Days
Efficacy of adalimumab Injection though changes in Optic Nerve Cup-to-Disk Ratio
Time frame: Every Two (2) Weeks After Implantation/Injection until Day 30
Efficacy of adalimumab Injection through incidences of Intraocular Inflammation
Time frame: 30 Days
Efficacy of adalimumab Injection through changes in the Ocular Coherence Tomography (OCT) of the Optic Nerves
Time frame: 30 Days
Efficacy of adalimumab Injection though changes in the ocular coherence tomography (OCT) of the Retina
Time frame: 30 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Dohlman, MD principal investigator
Massachusetts Eye and Ear
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adalimumab Injection in people with Penetrating Keratoplasty and Multiple Graft Failure, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
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 7 inclusion and 19 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: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Cheung, MSc, CCRP (617-573-6060, MCHEUNG0@MEEI.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Treatment Related Adverse Events. (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.