Repository Corticotropin Injection -Treatment Extension for Uveitis

1
Effectiveness
1
Safety
Cleveland Clinical Foundation, Cleveland, OH
Uveitis+6 More
Repository Corticotropin Injection -Treatment Extension - Drug
Eligibility
18+
All Sexes
Eligible conditions
Uveitis

Study Summary

Ocular Sarcoidosis Open Label Trial of ACTHAR Gel

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Eligible Conditions

  • Uveitis
  • Iridocyclitis
  • Panuveitis
  • Sarcoidosis
  • Uveitis, Anterior
  • Ocular Sarcoidosis
  • Anterior Uveitis (AU)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Repository Corticotropin Injection -Treatment Extension will improve 1 primary outcome and 3 secondary outcomes in patients with Uveitis. Measurement will happen over the course of Measured at 24 weeks.

Measured at 24 weeks
Proportion of patients experiencing a tapering of ocular/oral steroids by at least 50%
Proportion of patients with a clinically significant reduction-cystoid macular edema
Proportion of patients with clinically significant improvement in the resolution-intraocular inflammation
Proportion of patients with clinically significant improvement in visual acuity

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
H.P. Achtar Gel 80 U

This trial requires 9 total participants across 2 different treatment groups

This trial involves 2 different treatments. Repository Corticotropin Injection -Treatment Extension is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

H.P. Achtar Gel 80 UH.P. Acthar Gel (repository corticotropin) Injection, 80 U daily for 10 days, then 80 U twice weekly for up to a total of 24 weeks on therapy.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corticotropin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured at 24 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly measured at 24 weeks for reporting.

Closest Location

Cleveland Clinical Foundation - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Any posterior, intermediate or panuveitis of sufficient severity to warrant therapy, in the opinion of the treating physician --OR-- Anterior uveitis requiring 4 or more daily applications of topical corticosteroids to maintain control of inflammation, or uncontrolled with topical therapy
Persistent disease activity (active uveitis) at the time of screening
Patient with sarcoidosis as defined by ATS/ERS/WASOG guidelines (American Thoracic Society/European Respiratory Society /World Association of Sarcoidosis and Other Granulomatous Diseases)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can uveitis be cured?

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Contrary to long-term follow-up of other forms of arthritis, long-term follow-up of uveitis was poor across all studies in the systematic review. Thus, no evidence was found to suggest that uveitis can be cured.

Unverified Answer

What is uveitis?

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Vascular uveitis affects the central part of the eye. The eye should be checked every 12 months even if there are no eye symptoms. Uveitis can cause redness, itchiness, eye pain, blurred vision, glaucoma, cataracts, and in very severe cases, blindness. Uveitis can occur following an infection, allergic reaction, or traumatic optic nerve injury. The diagnosis of uveitis involves the differential diagnosis with various systemic diseases, such as multiple sclerosis, SLE, vasculitis, and thyroid disorders. It takes a multidisciplinary approach to help diagnose and treat uveitis.

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What causes uveitis?

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Autoimmune and viral infections are usually associated with uveitis. In general, if no infectious agent can be identified, and the inflammation is not present in the retina, the term non-infectious is appropriate. However, in certain circumstances, infectious causes of uveitis can be found such as syphilis and toxoplasmosis.

Unverified Answer

What are the signs of uveitis?

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Signs include the presence of a swollen eye.\n\nUrinary system diseases are not a single disorder and can be many in nature. Symptoms experienced by patients with urological disorders can be divided into four types; hematuria, urolithiasis, urinary retention and urinary tract infections.\n\nHematuria is the presence of the excretion of blood in the urine, usually due to a nephrolithiasis.\n\nTumors that can form in the kidney are very abundant and are caused by more than 85% of kidney tumors.\nThey can happen in the adrenal gland, testicles, ovary, bladder, stomach, prostate, and the skin.

Unverified Answer

How many people get uveitis a year in the United States?

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Nearly 40 million adults have uveitis at some point in their life. Men are more commonly affected than women. The highest rates of uveitis are seen among persons age <25 years. Individuals with HLA-B27 and/or rheumatoid arthritis are more likely to develop chronic idiopathic multifocal optic neuropathy.

Unverified Answer

What are common treatments for uveitis?

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Uveitis associated with systemic autoimmune diseases is frequently treated with corticosteroids and/or corticosteroid-sparing agents such as immunosuppressive drugs, with varying success rates. In patients with a predisposition to a relapsing course, the choice between immunosuppressive or other agents may be more complex and may include considerations of the risks versus the benefits. In refractory cases, immunotherapy with various medications including azathioprine, ciclosporin and methotrexate may be of benefit. The success of ciclosporin treatment has been demonstrated to be associated with immunomodulation and inhibition of the T and B cell subsets by this immunosuppressive drug.

Unverified Answer

Who should consider clinical trials for uveitis?

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The present study suggests that an improved knowledge of uveitis characteristics might result in a lower incidence of uveitis and, therefore, better treatment. Clinical trials should be made widely available, including long-term data on uveitis.

Unverified Answer

Has repository corticotropin injection -treatment extension proven to be more effective than a placebo?

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The administration of a single intrathecal bolus dose of human corticotropin is not effective for relieving the symptoms of acute ocular steroid-responsive uveitis. There is limited evidence to support the use of intrathecally delivered steroids in acute uveitis of any cause. Results from a recent clinical trial suggests that there may be room to apply these medications even for patients with acute uveitis which has poor response to oral corticosteroids. Additional controlled studies are needed to address the effectiveness of this therapy.

Unverified Answer

Have there been any new discoveries for treating uveitis?

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Uveitis patients are not unique. Other people have many different uveitis symptoms and many different causes for inflammation to the eye, and are being treated similarly and at similar costs to patients with uveitis. The lack of new pharmaceutical developments is probably explained by the fact that the uveitis is not a serious condition. Patients are usually in control of their eye problems, and most patients do not need any prescription medicines. It is possible that some patients might benefit from new discoveries on treatments, and maybe even some have already had some success when they went to the doctor. Unfortunately, that’s not something we have any control over.

Unverified Answer

Have there been other clinical trials involving repository corticotropin injection -treatment extension?

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Results from a recent paper showed that this a well tolerated treatment with limited side effects. This type of treatment may be extended to treat other conditions.

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What is the average age someone gets uveitis?

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There were statistically significant differences between each uveitic group, but there was not a single age group or gender that showed a large difference in uveitis prevalence among all the uveitic groups. The average age for all uveitic groups was 45.0 years.

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What does repository corticotropin injection -treatment extension usually treat?

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The extended treatment with corticotropin is effective and easy to administer. The high incidence of adverse effects, however, are of concern to the patients when withdrawing from the protocol. The long-term results show a gradual improvement of steroid sensitivity.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Uveitis by sharing your contact details with the study coordinator.