Actively Recruiting
Use of Acthar Gel Single-Dose Pre-Filled SelfJect Injector in Moderate-Severe Keratitis and Autoimmune Disease with Corneal Nerve and Pain Assessment
Led by Toyos Clinic · Updated on 2025-05-11
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Acthar Gel injected subcutaneously via a single-dose pre-filled SelfJect injector in patients with moderate to severe keratitis related to systemic autoimmune diseases and associated dry eye. This open-label pilot study involves 20 autoimmune patients who have demonstrated a peripheral corneal pain component through the proparacaine challenge. The study aims to assess improvements in symptoms related to ocular pain, corneal nerve appearance and function, and common neuropathic pain symptoms caused by dysfunctional nerves due to autoimmune inflammatory disease. Participants will receive 80 units of Acthar Gel twice weekly using the SelfJect injector for 12 weeks. This treatment is intended to improve the subjective sensation of ocular pain, conjunctival and corneal staining, and corneal nerve health as visualized by confocal microscopy and Cochet-Bonnet esthesiometry. The study includes one active treatment arm where at least 16 patients will complete the 12-week dosing period. Patients will be followed for up to 3 years after treatment to monitor changes in visual acuity, corneal and conjunctival staining, and neuropathic pain symptoms. During the study, participants will be assessed using various visual analog scales (VAS) for injection comfort, burning, stinging, and light sensitivity over the 3-year follow-up period. Confocal imaging will be used to evaluate corneal nerves, and patient-reported outcomes will track neuropathic pain symptoms and comfort with the SelfJect injector. Safety and symptom improvements will be monitored regularly, with continued observation for long-term changes after the treatment period ends.
CONDITIONS
Brief Title
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject can read, understand, and sign informed consent.
- Willing to comply with all study procedures and available for the study duration.
- Male or female aged 18 to 85 years.
- Normal eyelid anatomy.
- Diagnosed with dry eye for at least 6 months prior to enrollment.
- Symptom Bother score at baseline of 50.6 or greater.
- Diagnosis of any autoimmune disease.
- Presence of one or more corneal neuromas on baseline confocal microscopy.
- Partial or total relief of corneal pain with one drop of proparacaine after 15 minutes.
- No prior use of Acthar Gel SelfJect or other forms of Acthar Gel.
You will not qualify if you...
- Known hypersensitivity or contraindication to the investigational product or its components.
- Unwillingness to participate in study activities or attend study visits.
- Current pregnancy or lactation; unwillingness to use effective birth control during and four weeks after treatment.
- Use of antihistamines, mast cell stabilizers, or prescription eye drops within 24 hours prior to screening unless dose stable for 14 days.
- Current or recent (within 30 days) use of cenegermin, topical nerve growth factor, or platelet rich plasma.
- Treatment with another investigational drug or intervention within 30 days of screening.
- Serious or uncontrolled medical conditions that could affect study assessments, compliance, or safety.
- Use of systemic medications known to cause dry eye unless stable for at least 30 days.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive twice weekly injections of Acthar Gel via single-dose pre-filled SelfJect injector for 12 weeks to improve symptoms of keratitis and autoimmune disease.
Twice weekly visits for 12 weeks
Duration - Up to 3 years
Participants are followed for up to 3 years after treatment to assess changes in visual acuity, corneal and conjunctival staining, and neuropathic corneal pain symptoms.
Visits scheduled periodically during follow-up
Trial Site Locations
Total: 1 location
1
Toyos Clinic
Nashville, Tennessee, United States, 37215
Actively Recruiting
Research Team
H
Harley cheney Study Coordinator, Study Coordinator
M
Melissa Toyos, MD, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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