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Corticosteroid

ACTH Gel for Scleritis (ATLAS Trial)

Phase 2

Recruiting

Led By David K Scales, MD

Research Sponsored by Metropolitan Eye Research & Surgery Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving no other treatment or receiving prednisone and/or at least 1 other systemic immunosuppressant

Have active scleirits with characteristic clinical presentation and scleral inflammation ranging from +1 to +3

Must not have

Intraocular surgery within 90 days prior to Day 0 in the study eye

Presence of ocular or periocular infection in either eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline (bl) and monthly visits after screening

Awards & highlights

Summary

This trial will help researchers understand if a gel form of the hormone ACTH can help manage scleritis, an inflammatory disease affecting the eye.

Who is the study for?

Adults over 18 with non-infectious scleritis, a painful eye condition causing redness and blurred vision, can join this trial. They must have stable immune therapy use for the past month and no plans for eye surgery in six months. Participants need to be on or require systemic treatment for inflammation and agree to use contraception if applicable.

What is being tested?

The ATLAS study tests two doses of ACTH gel injected under the skin as a potential treatment for scleritis over 12 months. ACTH is already used for other inflammatory conditions like lupus and MS, so researchers hope it will reduce eye inflammation in scleritis too.

What are the potential side effects?

ACTH gel may cause side effects similar to steroids since it stimulates their production: increased appetite, mood changes, high blood pressure, fluid retention leading to swelling in limbs, elevated sugar levels in diabetics, and possible increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not on any treatment or I am taking prednisone and/or another immune-suppressing drug.

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I have active inflammation in my eye with a severity score between +1 and +3.

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I have an ongoing eye inflammation that needs treatment.

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I have active eye inflammation not caused by an infection and need treatment.

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I have inflammation in the front part of my eye.

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I am able to bear children, have a negative pregnancy test, and use birth control.

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My condition needs treatment with medication that affects my whole body.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had eye surgery in the last 90 days.

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I have an eye or area around the eye infection.

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I have not received a live vaccine in the last 4 weeks.

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I have toxoplasmosis in at least one of my eyes.

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I have not been in a drug or device trial within the last 30 days and won't join another for 180 days.

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I have been treated with chemicals or radiation targeting my immune system.

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I have inflammation in the back part of my eye only.

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I have a serious eye condition that could affect my vision.

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I have a type of eye cancer in the eye being studied.

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I had eye surgery within the last 30 days.

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I haven't had major surgery in the last 8 weeks and don't plan any in the next 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline (bl) and monthly visits after screening

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline (bl) and monthly visits after screening

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (bl) and monthly visits after screening for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in degree of inflammation, based on the standardized scleritis grading scale.

Change in grade of pain on an 11-point pain intensity numerical rating scale (NRS).

Secondary study objectives

Best corrected visual acuity outcome

Changes in steroids dosage during study

Dosage of systemic corticosteroids outcome

+4 more

Other study objectives

Incidence and severity of ocular adverse events (AEs)

Incidence and severity of other AEs

Trial Design

2Treatment groups

Experimental Treatment

Group I: Twice Weekly Treatment ArmExperimental Treatment1 Intervention

Patients in this treatment arm will receive mandatory 80 U twice weekly treatment with SC ACTH (adrenocorticotropic hormone) gel, starting at the Baseline visit (Day 0) until end of week 16. Starting at week 17, the treatment will be administered on as needed basis, based on the retreatment criteria.

Group II: Thrice Weekly Treatment ArmExperimental Treatment1 Intervention

Patients in this treatment arm will receive mandatory 80 U thrice weekly treatment with SC ACTH (adrenocorticotropic hormone) gel, starting at the Baseline visit (Day 0) until end of week 16. Starting at week 16, the treatment will be administered on as needed basis, based on the retreatment criteria.

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

MallinckrodtIndustry Sponsor

201 Previous Clinical Trials

15,836 Total Patients Enrolled

1 Trials studying Scleritis

6 Patients Enrolled for Scleritis

Stanford UniversityOTHER

2,448 Previous Clinical Trials

17,492,364 Total Patients Enrolled

Ocular Imaging Research and Reading CenterOTHER

Media Library

ACTH Gel (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03465111 — Phase 2

Scleritis Research Study Groups: Twice Weekly Treatment Arm, Thrice Weekly Treatment Arm

Scleritis Clinical Trial 2023: ACTH Gel Highlights & Side Effects. Trial Name: NCT03465111 — Phase 2

ACTH Gel (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03465111 — Phase 2

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