Ignite Creation Date:
2024-05-06 @ 4:30 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05005637
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2021-08-10
Brief Title:
The Effectivity of Anti Tuberculosis Therapy in Idiopathic Uveitis With Positive IGRA
Sponsor:
Fakultas Kedokteran Universitas Indonesia
Organization:
Fakultas Kedokteran Universitas Indonesia
Study Overview
Official Title:
The Effectivity of Anti Tuberculosis Therapy in Idiopathic Uveitis With Positive Interferon Gamma Release Assay IGRA A Randomized Clinical Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The reported incidence of uveitis is 52 persons per year per 100000 population with a greater incidence estimated in developing countries including Indonesia Uveitis has challenges in diagnosis and therapy due to the existence of an immunological privilege mechanism so it is not easy to obtain diagnostic markers or provide appropriate therapy In uveitis a work-up examination looking for signs in the entire body or systemic disease is often conducted
Up until today establishing the diagnosis of tuberculosis TB-associated uveitis is still a challenge From histopathological studies TB germs are difficult to find Wreblowski et al found that paucibacillary conditions also made TB bacteria difficult to find by PCR and tuberculin test results were also not completely reliable The development of IGRA Interferon-Gamma Release Assay assays such as QuantiFERON-Gold TB QFT has been investigated Our previous study found that IGRA-positive uveitis patients with type 1 IFN gene expression score 561 were more likely to have active TB uveitis In addition serum C1q examination also showed an inverse correlation with this score
Regarding therapy until now corticosteroids and cycloplegics are the mainstay treatment for uveitis However appropriate administration of anti-infective drugs is necessary in cases of infection Inflammation in TB-associated uveitis is thought to be the result of the immune response that occurs as a result of paucibacillary TB infection Examinations can be redundant and problematic Determination of therapy is also a dilemma because it is difficult to determine the right patient candidate for administration of anti-tuberculosis therapy ATT The protocol of ATT administration itself has not been standardized so it often follows the extra pulmonary TB protocol and there has been no reliable clinical trial research on ATT administration in patients with suspected TB uveitis yet no TB microorganisms are found directly in the eyes or other organs
On this basis the investigators planned a prospective randomized clinical trial study that involve idiopathic uveitis patients with positive IGRA test to assess the effectivity of ATT compared to oral steroids In addition this study can also be used as a basis for validation of type 1 IFN scores and serum C1q as diagnosticprognostic biomarkers in cases of TB-associated uveitis
Up until today establishing the diagnosis of tuberculosis TB-associated uveitis is still a challenge From histopathological studies TB germs are difficult to find Wreblowski et al found that paucibacillary conditions also made TB bacteria difficult to find by PCR and tuberculin test results were also not completely reliable The development of IGRA Interferon-Gamma Release Assay assays such as QuantiFERON-Gold TB QFT has been investigated Our previous study found that IGRA-positive uveitis patients with type 1 IFN gene expression score 561 were more likely to have active TB uveitis In addition serum C1q examination also showed an inverse correlation with this score
Regarding therapy until now corticosteroids and cycloplegics are the mainstay treatment for uveitis However appropriate administration of anti-infective drugs is necessary in cases of infection Inflammation in TB-associated uveitis is thought to be the result of the immune response that occurs as a result of paucibacillary TB infection Examinations can be redundant and problematic Determination of therapy is also a dilemma because it is difficult to determine the right patient candidate for administration of anti-tuberculosis therapy ATT The protocol of ATT administration itself has not been standardized so it often follows the extra pulmonary TB protocol and there has been no reliable clinical trial research on ATT administration in patients with suspected TB uveitis yet no TB microorganisms are found directly in the eyes or other organs
On this basis the investigators planned a prospective randomized clinical trial study that involve idiopathic uveitis patients with positive IGRA test to assess the effectivity of ATT compared to oral steroids In addition this study can also be used as a basis for validation of type 1 IFN scores and serum C1q as diagnosticprognostic biomarkers in cases of TB-associated uveitis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None