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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03886233
Other study ID # IRB000188
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2019
Est. completion date February 2021

Study information

Verified date March 2019
Source Assiut University
Contact Elham Y Ahmed, Bachelor
Phone 01144710803
Email elhamyoussef06@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date February 2021
Est. primary completion date February 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04126850 - Pilot Project: The Amplicon and Metatranscriptomic Study of Intra and Extra Intestinal Microbiome in Non-infectious Uveitis Disease