Treatment Outcome of Uveitis in Autoimmune Diseases

reviewing the outcomes of patients with uveitis caused by autoimmune diseases treated at Assiut University Hospital at the Ophthalmology and Rheumatology and Rehabilitation Departments.

Study Overview

• Status: Unknown
• Conditions: Autoimmune Uveitis
• Intervention / Treatment: Drug: Corticosteroid Series

Detailed Description

Autoimmune uveitis (AU) is an inflammation of the uvea caused by either an autoimmune reaction to self-antigens or an innate inflammatory reaction secondary to an external stimulus. Corticosteroids are considered the gold standard in management of acute AU, but it is necessary to combine them with other immunosuppressive drugs. Finally, biological anti-inflammatory agents (for exapmle antagonists of tumor necrosis factor alpha like Infliximab and adalimumab) are also showing very promising results. Follow-up visits of subjects with uveitis must be frequent and focused on monitoring the recurrence of acute outbreaks, , if any. They should be aimed to determine the evolution of inflammatory signs until their complete resolution, thus ensuring the least possible consequences. After the initial phase of the treatment, the duration of use of the maintenance medication is directly related to the diagnosis, treatment and control of the underlying disease. This will help to determine if a patient is badly controlled and requires a more aggressive therapeutic plan. Also, a complete physical exam must be done each time the patient sees to the physician in order to monitor ophthalmological complications or development of adverse effects secondary to the treatment.

• Study Type: Observational
• Enrollment (Anticipated): 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will include uveitis caused by autoimmune diseases. Uveitis can be anterior (including iritis or iridocyclitis). Intermediate uveitis or vitritis involves the vitreous cavity and may involve the pars plana. Finally, posterior uveitis is divided in three types: choroiditis, retinochoroiditis, and chorioretinitis. In diffuse involvement or when uveitis affects many areas, it is described as panuveitis.

Description

Inclusion Criteria:

• Uveitis with clinical features of autoimmune disease;

Exclusion Criteria:

• Other infectious and non-infectious uveitic etiologies that may mimic the given clinical presentation of autoimmune uveitis;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Traditional Treatment for Autoimmune uveitis; Corticosteroids are considered the gold standard in management of acute AU. They can only be administered after excluding infectious origin. Their use for prolonged time and/ or in high doses may be associated with serious adverse events . Therefore, it is necessary to combine them with other immunosuppressive drugs.Based on their mechanism of action, immunosuppressives are divided into alkylating agents (cyclophosphamide and chlorambucil), antimetabolites (methotrexate, azathioprine, and Mycophenolate Mofetil), and calcineurin inhibitors (cyclosporine, tacrolimus and sirolimus).Dosage form, dosage, frequency and duration differ according to age and case severity.	Drug: Corticosteroid Series; immunosuppressives are divided into alkylating agents (cyclophosphamide and chlorambucil), antimetabolites (methotrexate, azathioprine, and Mycophenolate Mofetil), and calcineurin inhibitors (cyclosporine, tacrolimus and sirolimus) Biological anti-inflammatory agents (for exapmle antagonists of tumor necrosis factor alpha like Infliximab and adalimumab).; Other Names: Immunosuppressive drugs; Biological therapy
Biological Treatment for Autoimmune uveitis; Biological anti-inflammatory agents (for exapmle antagonists of tumor necrosis factor alpha like Infliximab and adalimumab) are also showing very promising results. In many cases, these agents will be seen listed as first choice in some autoimmune diseases, depending on the patient's history, age, sex, type and severity of the inflammatory disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
determination the best method for treatment of autoimmune uveitis	compare the rates of treatment failure in the management of autoimmune uveitis between patients who received steroids, immunosuppressive drugs or biological therapies.	2 years

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Hasan L Fahmy, Prof., Assiut University; Study Director: Mohamed G Saleh, lecturer, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Eye Diseases; Uveal Diseases; Autoimmune Diseases; Uveitis; Physiological Effects of Drugs; Immunologic Factors; Immunosuppressive Agents
• Other Study ID Numbers: IRB000188

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No