Treatment Outcome of Uveitis in Autoimmune Diseases

• ClinicalTrials.gov Identifier: NCT03886233
• Recruitment Status: Unknown
• First Posted: March 22, 2019
• Last Update Posted: March 22, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Elham youssif Ahmed Ali, Assiut University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Autoimmune Uveitis	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 Design

• Study Type: Observational
• Estimated Enrollment: 1 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Treatment Outcome of Uveitis in Autoimmune Diseases
• Estimated Study Start Date: March 2019
• Estimated Primary Completion Date: February 2021
• Estimated Study Completion Date: February 2021

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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;

Contacts and Locations

Contacts

Contact: Elham Y Ahmed, Bachelor; 01144710803; elhamyoussef06@gmail.com

Sponsors and Collaborators

Assiut University

Investigators

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

More Information

• Responsible Party: Elham youssif Ahmed Ali, Assiut, Assiut University
• ClinicalTrials.gov Identifier: NCT03886233
• Other Study ID Numbers: IRB000188
• First Posted: March 22, 2019
• Last Update Posted: March 22, 2019
• Last Verified: March 2019

• 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

Additional relevant MeSH terms:

Uveitis; Autoimmune Diseases; Uveal Diseases; Eye Diseases; Immune System Diseases; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs