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This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab (Humira) | Experimental | This arm will receive the study intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab Injection | Drug | 10% (4.0mg/0.04ml) dissolved in sterile saline to be injected once during the time of the Boston Keratoprosthesis (Kpro) Surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 Days |
| Efficacy of adalimumab Injection though changes in Optic Nerve Cup-to-Disk Ratio |
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Inclusion Criteria:
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
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Cheung, MSc, CCRP | Contact | 617-573-6060 | MCHEUNG0@MEEI.HARVARD.EDU |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Dohlman, MD | Massachusetts Eye and Ear | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D010390 | Pemphigoid, Benign Mucous Membrane |
| D013262 | Stevens-Johnson Syndrome |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
This efficacy outcome measure will be analyzed through any changes to the cup-to-disk ratio. A normal ratio is 0.2mm |
| 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. | 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). | 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). | 30 Days |
| D017437 |
| Skin and Connective Tissue Diseases |
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D004892 | Erythema Multiforme |
| D004890 | Erythema |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |