Treatment Outcome of Uveitis in Autoimmune Diseases

NCT03886233 | Unknown FDA Drug

• 1 other identifier: IRB000188
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autoimmune Uveitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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.

Interventions

Corticosteroid Series DRUG

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).

Also known as: Immunosuppressive drugs, Biological therapy

Traditional Treatment for Autoimmune uveitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Uveitis with clinical features of autoimmune disease;

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Biological Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Hasan L Fahmy, Prof.

  Assiut University

  STUDY CHAIR

• Mohamed G Saleh, lecturer

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Elham Y Ahmed, Bachelor

CONTACT

01144710803; elhamyoussef06@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assiut

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 22, 2019
• Study Start: March 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 22, 2019

Record last verified: 2019-03