The Effectivity of Anti Tuberculosis Therapy in Idiopathic Uveitis with Positive IGRA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-27

Study Completion Date

2024-11-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Tuberculous Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Anti Tuberculosis Therapy

Dosage form: ATT fixed-dose combination (FDC). FDC intensive phase containing 150 mg of rifampicin, 75 mg of isoniazid not 300mg, 400 mg of pyrazinamide, and 275 mg of ethambutol, while FDC continuation phase containing rifampicin-isoniazid.

Dosage: 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.

Frequency: Intensive phase: once daily. Continuation phase: 3 times/week. Duration: 9 months (2 months of FDC intensive phase + 7 months of FDC continuation phase)

Group Type EXPERIMENTAL

Anti Tuberculosis Drug

Intervention Type DRUG

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.

Steroid Local and Oral

Local steroids were prescribed according to the standard care by the attending uveitis specialists and tailored to the severity of the intraocular inflammation. Additionally, all participants in this group received oral methylprednisolone at a dosage of 0.8 mg/kg of body weight per day (maximum of 56 mg/day), which was tapered gradually based on the intraocular inflammation observed. Tapering of oral methylprednisolone involved reducing the dose by 8 mg for doses above 20 mg and by 4 mg for doses below 20 mg.

Group Type ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type DRUG

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.

Interventions

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Anti Tuberculosis Drug

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.

Intervention Type DRUG

Methylprednisolone

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patient that is newly diagnosed with uveitis of unknown origin/idiopathic (as evidenced by a series of uveitis work-up tests) and tested positive for IGRA (\>0.35 U/ml).
2. Age \>18 years old
3. Lives in Jakarta/Bogor/Depok/Tangerang/Bekasi area or willing to participate in research until the end of monitoring program
4. Willing to participate in the research and sign the informed consent after receiving explanation regarding the research

Exclusion Criteria

1. Patients with positive aqueous tap examination results on one of the examination panels for the bacteria causing infectious uveitis according to the standard examination
2. Anterior uveitis patient with a positive HLA-B27 test result
3. The patient is proven to have active TB or lives in the same house with an active TB patient
4. Patients are included in the TB reactivation risk index group according to the 2018 WHO LTBI (Latent Tuberculosis Incident) Guideline
5. HIV positive patient
6. Patients with uveitis sanata at the first visit
7. Patients with visual acuity less than 1/300 or showing signs of preptisis based on ophthalmological examination and ultrasound of the eye
8. The patient has a history of previous ATT consumption
9. Patients with impaired liver function or other systemic conditions which according to the Internal Medicine Department are not eligible to receive ATT
10. The patient has a history of taking antibiotics in the last 1-2 weeks
11. The patient is not willing to sign the informed consent
12. The patient was pregnant at the first visit or was planning to become pregnant during the study period

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No