At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Antitubercular Treatment for Uveitis of Undetermined Cause with Positive QuantiFERON-TB Gold Plus: a Randomized Clinical Trial
In Brief
A Phase 2 clinical trial evaluating Anti Tuberculosis Drug and Methylprednisolone for Tuberculous Uveitis. Completed, enrolled 78 participants across 1 site.
Detailed Summary
The reported incidence of uveitis is 52 persons per year per 100,000 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 \>5.61 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 diagnostic/prognostic biomarkers in cases of TB-associated uveitis.
Study Details
Timeline
Interventions
ATT will be given in the form of fixed drug combination (FDC). Each patient will get a regimen of 2RHZE (2 months of FDC intensive phase, which contains of Rifampicin, Isoniazide, Pirazinamide, Ethambutol) + 7RH (7 months of FDC continuation phase, which contains of Rifampicin and Isoniazid). The dosage will be according to body weight, 30-37 kg: 2 tablets, 38-54 kg: 3 tablets, 55-70 kg: 4 tablets, more than 70 kg: 5 tablets. FDC drugs have to be consumed daily during intensive phase and three times a week during continuation phase.
Selected participants may be prescribed local or systemic immunosuppressants, including oral methylprednisolone, starting at a dosage of 0.8 mg/kg of body weight per day and tapered gradually (e.g., every three days or weekly) based on the severity of intraocular inflammation observed during presentation and follow-up visits.