Using Acthar Gel to treat moderate-severe keratitis in autoimmune patients

A Phase 4 Pilot Study With Extension to Assess the Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease and the Effect on Corneal Nerves and Neuropathic Corneal Pain

This study is testing if Acthar Gel can help people with autoimmune diseases and dry eye feel less eye pain and improve their eye health over 12 weeks.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Toyos Clinic (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06964269 on ClinicalTrials.gov

What this trial studies

This pilot study involves 20 patients with autoimmune diseases and dry eye, who will receive Acthar Gel via a pre-filled injector for 12 weeks. The study aims to assess the effects of the treatment on ocular pain, corneal nerve function, and overall eye health. Participants will undergo various assessments, including confocal imaging and pain scales, to evaluate the treatment's efficacy. Follow-up will continue for up to three years to monitor long-term outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with a diagnosis of dry eye and an autoimmune disease, experiencing corneal pain.

Not a fit: Patients with known hypersensitivity to Acthar Gel or those who have previously used it will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate ocular pain and improve eye function in patients with autoimmune-related keratitis.

How similar studies have performed: While this approach is novel, similar studies have shown promise in treating ocular pain associated with autoimmune conditions.

Eligibility criteria

Inclusion Criteria:

1. Subject can read, understand, sign and informed consent.
2. Provision of signed and dated informed consent form and HIPPA authorization.
3. Stated willingness to comply with all study procedures and availability
4. for the duration of the study
5. Male or female aged 18-85 years.
6. Normal eyelid anatomy
7. Patients diagnosed with dry eye for at least 6 months prior to enrollment.
8. Patients with Symptom Bother score at Baseline of 50.6 or greater.
9. Patients with a diagnosis of any autoimmune disease.
10. Patients with one or more corneal neuroma as seen on baseline confocal microscopy.
11. Patients with partial or total relief of corneal pain with one drop of proparacaine over 15 minutes post-instillation.
12. No prior use of Acthar Gel SelfJect or otherwise for any indication.

Exclusion Criteria:

* 1\. Have a known hypersensitivity or contraindication to the investigational product or their components.

  2\. Unwilling to participate in study activities or report for study visits. 3. Current pregnancy or lactation per self-report. Patients who are unwilling to use an effective method of birth control while participating in the study and for four weeks after the last dose of study drug is administered.

  4\. Use of antihistamines, mast cell stabilizers, or prescription eye drops within 24 hours prior to screening and for the study, unless the dose has been stable for 14 days.

  5\. Current use of cenegermin, topical nerve growth factor or platelet rich plasma or use within the past 30 days.

  6\. Treatment with another investigational drug or other intervention within 30 days of screening.

  7\. Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments, limit compliance, or pose safety risks.

  8\. Systemic medications known to cause dry eye should not be used including antimuscarinics, antihistamines, vitamin A analogs, antianxiety agents, and others unless stable for at least 30 days.

Where this trial is running

Nashville, Tennessee

• Toyos Clinic — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Harley cheney Study Coordinator, Study Coordinator

Conditions Autoimmune Diseases; Dry Eye; Neurotrophic Keratitis; Dry eye; Autoimmune; Neurotropic Keratitis