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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (bl) and monthly visits after screening
Awards & highlights
ATLAS Trial 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.Check my eligibility
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.See study design
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.
ATLAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I have an ongoing eye inflammation that needs treatment.
Select...
I have active eye inflammation not caused by an infection and need treatment.
Select...
I have inflammation in the front part of my eye.
Select...
I am able to bear children, have a negative pregnancy test, and use birth control.
Select...
My condition needs treatment with medication that affects my whole body.
Select...
I am 18 years old or older.
ATLAS Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Best corrected visual acuity outcome
Changes in steroids dosage during study
Dosage of systemic corticosteroids outcome
+4 moreOther outcome measures
Incidence and severity of ocular adverse events (AEs)
Incidence and severity of other AEs
ATLAS 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.
Find a Location
Who is running the clinical trial?
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,198 Total Patients Enrolled
1 Trials studying Scleritis
6 Patients Enrolled for Scleritis
Stanford UniversityOTHER
2,394 Previous Clinical Trials
17,341,580 Total Patients Enrolled
Ocular Imaging Research and Reading CenterOTHER
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have eye problems related to scleritis.I am not on any treatment or I am taking prednisone and/or another immune-suppressing drug.I am not planning to have eye surgery within the next 6 months.You have an eye condition that makes it difficult for the doctor to see inside your eye.I haven't had specific immune treatments recently.I do not plan to have eye surgery in the next 6 months.I have not had eye surgery in the last 90 days.I have active inflammation in my eye with a severity score between +1 and +3.I have an ongoing eye inflammation that needs treatment.I have an eye or area around the eye infection.I have not received a live vaccine in the last 4 weeks.I have active eye inflammation not caused by an infection and need treatment.I agree to use barrier methods of contraception.I haven't had any treatments on my study eye in the last 90 days.I have inflammation in the front part of my eye.I have been on a stable dose of immune therapy for at least 4 weeks.I have toxoplasmosis in at least one of my eyes.I am able to bear children, have a negative pregnancy test, and use birth control.I have not been in a drug or device trial within the last 30 days and won't join another for 180 days.I have been treated with chemicals or radiation targeting my immune system.I have scleritis due to a systemic disease but my treatment for it won't change.My condition needs treatment with medication that affects my whole body.I have inflammation in the back part of my eye only.I have a serious eye condition that could affect my vision.I am 18 years old or older.I have a type of eye cancer in the eye being studied.I have been diagnosed with a type of eye inflammation that is not caused by an infection.I had eye surgery within the last 30 days.I haven't had major surgery in the last 8 weeks and don't plan any in the next 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Twice Weekly Treatment Arm
- Group 2: Thrice Weekly Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there potential hazards associated with ACTH (adrenocorticotropic hormone) gel use?
"A score of 2 was assigned to ACTH gel in terms of safety as the Phase 2 trial revealed some evidence for its security however no data currently exists that confirms its efficacy."
Answered by AI
In what cases are ACTH (adrenocorticotropic hormone) gels typically recommended?
"ACTH (adrenocorticotropic hormone) gel is an effective therapeutic for acute coryza, rheumatoid arthritis, juvenile and optic neuritis."
Answered by AI
What is the current enrollment count for this research protocol?
"Affirmative. The clinicaltrial.gov listing of this trial confirms that it is presently enrolling participants, having been initially posted on January 1st 2019 and most recently updated July 9th 2022. 30 individuals are being recruited from three different locations for the study's duration."
Answered by AI
What is the ultimate aim of this research project?
"This trial aims to assess the efficacy of its intervention by evaluating changes in inflammation levels, vascular leakage, corticosteroid dosage and scleral thickness. These parameters will be measured at baseline, week 16 and 52 or when rescue therapies are required. Secondary objectives include assessment of vascular leakage using fluorescence angiography; recording dosages of systemic corticosteroids and measuring scleral thickness via spectral-domain optical coherence tomography (OCT)."
Answered by AI
Is the research team currently looking for participants?
"According to clinicaltrials.gov, this research is currently enrolling patients. It was initially publicized on January 1st 2019 and the most recent update came through on July 9th 2022."
Answered by AI
Are there any precedential studies that incorporated ACTH (adrenocorticotropic hormone) gel?
"Presently, nine trials are investigating ACTH (adrenocorticotropic hormone) gel with two of them in the advanced phase 3 stage. Although the majority of these experiments take place at Minneapolis, Minnesota, other medical centres across 104 sites have joined forces to advance this novel treatment."
Answered by AI
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