Tuberculous UveitisPhase 2NCT05005637
The Effectivity of Anti Tuberculosis Therapy in Idiopathic Uveitis with Positive IGRA
A Phase 2 study testing Anti Tuberculosis Drug and Methylprednisolone in people with Tuberculous Uveitis, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculous Uveitis
- What is being tested?
- Anti Tuberculosis Drug and Methylprednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Aug 2021to 20 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Age >18 years old
- Lives in Jakarta/Bogor/Depok/Tangerang/Bekasi area or willing to participate in research until the end of monitoring program
- Willing to participate in the research and sign the informed consent after receiving explanation regarding the research
Who cannot join
- Patients with positive aqueous tap examination results on one of the examination panels for the bacteria causing infectious uveitis according to the standard examination
- Anterior uveitis patient with a positive HLA-B27 test result
- The patient is proven to have active TB or lives in the same house with an active TB patient
- Patients are included in the TB reactivation risk index group according to the 2018 WHO LTBI (Latent Tuberculosis Incident) Guideline
- HIV positive patient
- Patients with uveitis sanata at the first visit
Show all 12Show fewer
- Patients with visual acuity less than 1/300 or showing signs of preptisis based on ophthalmological examination and ultrasound of the eye
- The patient has a history of previous ATT consumption
- Patients with impaired liver function or other systemic conditions which according to the Internal Medicine Department are not eligible to receive ATT
- The patient has a history of taking antibiotics in the last 1-2 weeks
- The patient is not willing to sign the informed consent
- The patient was pregnant at the first visit or was planning to become pregnant during the study period
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo National Central General Hospital
Jakarta Pusat, DKI Jakarta, 10320
About this study
Official title: Antitubercular Treatment for Uveitis of Undetermined Cause with Positive QuantiFERON-TB Gold Plus: a Randomized Clinical Trial
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.
Read more
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.
- Conditions
- Tuberculous Uveitis
- Being tested
- Anti Tuberculosis Drug, Methylprednisolone
- Keywords
- Tuberculosis, Uveitis, Tuberculous Uveitis, Idiopathic Uveitis, Interferon Gamma Release Assay, Anti Tuberculosis Therapy, IGRA, ATT, Quantiferon-TB GoldPlus
- Medical subject headings
- Tuberculosis, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti Tuberculosis DrugDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Anti Tuberculosis Therapy | Experimental | 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) Receives: Drug: Anti Tuberculosis Drug |
| Steroid Local and Oral | Active comparator | 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. Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Treatment Failure
Treatment will be categorized as a failure if subject did not meet the following criteria at the 6-month follow-up post initial therapy, (1) less than or equal to 0.5+ anterior chamber cells by SUN criteria, less than or equal to 0.5+ vitreous haze clinical grading using the NEI scale, and no active retinal or choroidal lesions; and (2) no more than 7.5 mg of oral prednisone daily and less than or equal to 2 drops of prednisolone acetate 1% (or equivalent) per day; or in other words, the subject has persistent inflammation that keeps getting worse.
Measured: 6 months after the initial therapy
Response to Treatment
Criteria for complete uveitis resolution applied to both eyes, in cases with bilateral uveitis, included: (1) fewer than or equal to 0.5+ anterior chamber cells according to the Standardized Uveitis Nomenclature (SUN) grading system, fewer than or equal to 0.5+ vitreous haze based on clinical grading using the NEI (National Eye Institute) scale, and no active retinal or choroidal lesions; and (2) no more than 7.5 mg of oral prednisone daily (i.e., methylprednisolone at 6 mg or less daily) and fewer than or equal to 2 drops of prednisolone acetate 1% (or equivalent) per day. Treatment will be categorized as a failure if subject did not meet the following criteria at the 6-month follow-up.
Measured: 6 months after initial treatment
Secondary outcomes (4)
Time to Uveitis Resolution
Calculated from the time of randomization. These criteria had to be maintained for at least 90 days following the visit when the first complete uveitis resolution was recorded. If there was insufficient follow-up after resolution, maintained uveitis resolution was still considered. Participants who met criterion 1 but not criterion 2 were classified as having partial uveitis resolution (non-complete uveitis resolution).
This was measured every visit using objectives of ophthalmologist's clinical judgement from slit-lamp examination and clinical complaints.
Measured: 90 days after the visit of first uveitis resolution was recorded
Uveitis Relapse
Uveitis relapse was defined as any worsening of ocular inflammation (including a two-step increase in anterior chamber or vitreous cells as per the SUN grading system) or the occurrence of clinically new inflammatory activity (such as choroidal or retinal lesions) that necessitated a modification of local or systemic uveitis treatment after a minimum of 90 days of complete uveitis resolution at the patient level.
Time to relapse was calculated from the first visit showing inactive uveitis until the first notification of uveitis relapse.
Measured: 6 months after the initial therapy
Eye-Level outcome (Visual Acuity)
The differences in visual acuity between baseline and month 6.Visual acuity was considered to increase if the difference in best-corrected visual acuity between month 6 and baseline visits (measured with Snellen, in decimal equivalent) was equal to or greater than 0.1, stable if within the range of -0.1 to 0.1, and decreased if less than -0.1. If any cataract or vitreoretinal surgery was performed before the six-month follow-up, the last recorded visual acuity prior to the surgery was used.
Measured: 6 months after baseline visit
Eye-Level outcome (Secondary glaucoma)
The incidence of secondary glaucoma (e.g., occurrences of increased intraocular pressure (IOP) above 21 mmHg in at least two consecutive visits that necessitated prescription of IOP-lowering medications).
Measured: 6 months after baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start27 Aug 2021
- Primary completion20 Oct 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Tuberculous UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rina, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Rina La Distia Nora, MD, PhD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005637
- Sponsor's protocol ID
- 06/DIPI/2021
- Status last verified
- Feb 2025
- First submitted
- 10 Aug 2021
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Putera I, Ten Berge JCEM, Thiadens AAHJ, Dik WA, Agrawal R, van Hagen PM, La Distia Nora R, Rombach SM. Relapse in ocular tuberculosis: relapse rate, risk factors and clinical management in a non-endemic country. Br J Ophthalmol. 2024 Nov 22;108(12):1642-1651. doi: 10.1136/bjo-2024-325207.
PubMed 38609164Putera I, Ten Berge JCEM, Thiadens AAHJ, Dik WA, Agrawal R, van Hagen PM, La Distia Nora R, Rombach SM. Clinical Features and Predictors of Treatment Outcome in Patients with Ocular Tuberculosis from the Netherlands and Indonesia: The OculaR TB in Low versus High Endemic Countries (ORTEC) Study. Ocul Immunol Inflamm. 2025 Jan;33(1):86-97. doi: 10.1080/09273948.2024.2359614. Epub 2024 May 31.
PubMed 38820475Putera I, Schrijver B, Ten Berge JCEM, Gupta V, La Distia Nora R, Agrawal R, van Hagen PM, Rombach SM, Dik WA. The immune response in tubercular uveitis and its implications for treatment: From anti-tubercular treatment to host-directed therapies. Prog Retin Eye Res. 2023 Jul;95:101189. doi: 10.1016/j.preteyeres.2023.101189. Epub 2023 May 25.
PubMed 37236420Ludi Z, Sule AA, Samy RP, Putera I, Schrijver B, Hutchinson PE, Gunaratne J, Verma I, Singhal A, Nora RD, van Hagen PM, Dik WA, Gupta V, Agrawal R. Diagnosis and biomarkers for ocular tuberculosis: From the present into the future. Theranostics. 2023 Apr 1;13(7):2088-2113. doi: 10.7150/thno.81488. eCollection 2023.
PubMed 37153734La Distia Nora R, Sitompul R, Bakker M, Susiyanti M, Edwar L, Sjamsoe S, Singh G, van Hagen MP, Rothova A. Tuberculosis and other causes of uveitis in Indonesia. Eye (Lond). 2018 Mar;32(3):546-554. doi: 10.1038/eye.2017.231. Epub 2017 Nov 3.
PubMed 29099497Betzler BK, Putera I, Testi I, La Distia Nora R, Kempen J, Kon OM, Pavesio C, Gupta V, Agrawal R. Anti-tubercular therapy in the treatment of tubercular uveitis: A systematic review and meta-analysis. Surv Ophthalmol. 2023 Mar-Apr;68(2):241-256. doi: 10.1016/j.survophthal.2022.10.001. Epub 2022 Oct 19.
PubMed 36272559La Distia Nora R, Putera I, Riasanti M, Sitompul R, Edwar L, Susiyanti M, Aziza Y, Waliyuddin MZ, Widodo E, Sifyana UA, Jessica P, Ethelind R, Singh G, Dik WA, Rombach SM, van Hagen PM. Antitubercular therapy for uveitis of undetermined cause with positive interferon-gamma release assay: a single-blind, single-centre, phase 2 randomised controlled trial. EClinicalMedicine. 2025 Sep 17;88:103511. doi: 10.1016/j.eclinm.2025.103511. eCollection 2025 Oct.
PubMed 41018498
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antitubercular Treatment for Uveitis of Undetermined Cause with Positive QuantiFERON-TB Gold Plus: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05005637
- Acronym / sponsor ID
- 06/DIPI/2021
- Conditions
- Tuberculous Uveitis
- Keywords
- Tuberculosis, Uveitis, Tuberculous Uveitis, Idiopathic Uveitis, Interferon Gamma Release Assay, Anti Tuberculosis Therapy, IGRA, ATT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti Tuberculosis Therapy | Experimental | Drug: Anti Tuberculosis DrugDosage 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) |
| Steroid Local and Oral | Active comparator | Drug: MethylprednisoloneLocal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
- Age >18 years old
- Lives in Jakarta/Bogor/Depok/Tangerang/Bekasi area or willing to participate in research until the end of monitoring program
- Willing to participate in the research and sign the informed consent after receiving explanation regarding the research
Key exclusion criteria (12 listed)
- Patients with positive aqueous tap examination results on one of the examination panels for the bacteria causing infectious uveitis according to the standard examination
- Anterior uveitis patient with a positive HLA-B27 test result
- The patient is proven to have active TB or lives in the same house with an active TB patient
- Patients are included in the TB reactivation risk index group according to the 2018 WHO LTBI (Latent Tuberculosis Incident) Guideline
- HIV positive patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti Tuberculosis DrugATT 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. | Drug | Anti Tuberculosis Therapy |
| MethylprednisoloneSelected 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. | Drug | Steroid Local and Oral |
Primary outcome
Percentage of Treatment Failure
Time frame: 6 months after the initial therapy
Treatment will be categorized as a failure if subject did not meet the following criteria at the 6-month follow-up post initial therapy, (1) less than or equal to 0.5+ anterior chamber cells by SUN criteria, less than or equal to 0.5+ vitreous haze clinical grading using the NEI scale, and no active retinal or choroidal lesions; and (2) no more than 7.5 mg of oral prednisone daily and less than or equal to 2 drops of prednisolone acetate 1% (or equivalent) per day; or in other words, the subject has persistent inflammation that keeps getting worse.
Response to Treatment
Time frame: 6 months after initial treatment
Criteria for complete uveitis resolution applied to both eyes, in cases with bilateral uveitis, included: (1) fewer than or equal to 0.5+ anterior chamber cells according to the Standardized Uveitis Nomenclature (SUN) grading system, fewer than or equal to 0.5+ vitreous haze based on clinical grading using the NEI (National Eye Institute) scale, and no active retinal or choroidal lesions; and (2) no more than 7.5 mg of oral prednisone daily (i.e., methylprednisolone at 6 mg or less daily) and fewer than or equal to 2 drops of prednisolone acetate 1% (or equivalent) per day. Treatment will be categorized as a failure if subject did not meet the following criteria at the 6-month follow-up.
4 secondary outcomes
Time to Uveitis Resolution
Time frame: 90 days after the visit of first uveitis resolution was recorded
Uveitis Relapse
Time frame: 6 months after the initial therapy
Eye-Level outcome (Visual Acuity)
Time frame: 6 months after baseline visit
Eye-Level outcome (Secondary glaucoma)
Time frame: 6 months after baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 38609164Putera I, Ten Berge JCEM, Thiadens AAHJ, Dik WA, Agrawal R, van Hagen PM, La Distia Nora R, Rombach SM. Relapse in ocular tuberculosis: relapse rate, risk factors and clinical management in a non-endemic country. Br J Ophthalmol. 2024 Nov 22;108(12):1642-1651. doi: 10.1136/bjo-2024-325207.
- Background: PubMed 38820475Putera I, Ten Berge JCEM, Thiadens AAHJ, Dik WA, Agrawal R, van Hagen PM, La Distia Nora R, Rombach SM. Clinical Features and Predictors of Treatment Outcome in Patients with Ocular Tuberculosis from the Netherlands and Indonesia: The OculaR TB in Low versus High Endemic Countries (ORTEC) Study. Ocul Immunol Inflamm. 2025 Jan;33(1):86-97. doi: 10.1080/09273948.2024.2359614. Epub 2024 May 31.
- Background: PubMed 37236420Putera I, Schrijver B, Ten Berge JCEM, Gupta V, La Distia Nora R, Agrawal R, van Hagen PM, Rombach SM, Dik WA. The immune response in tubercular uveitis and its implications for treatment: From anti-tubercular treatment to host-directed therapies. Prog Retin Eye Res. 2023 Jul;95:101189. doi: 10.1016/j.preteyeres.2023.101189. Epub 2023 May 25.
- Background: PubMed 37153734Ludi Z, Sule AA, Samy RP, Putera I, Schrijver B, Hutchinson PE, Gunaratne J, Verma I, Singhal A, Nora RD, van Hagen PM, Dik WA, Gupta V, Agrawal R. Diagnosis and biomarkers for ocular tuberculosis: From the present into the future. Theranostics. 2023 Apr 1;13(7):2088-2113. doi: 10.7150/thno.81488. eCollection 2023.
- Background: PubMed 29099497La Distia Nora R, Sitompul R, Bakker M, Susiyanti M, Edwar L, Sjamsoe S, Singh G, van Hagen MP, Rothova A. Tuberculosis and other causes of uveitis in Indonesia. Eye (Lond). 2018 Mar;32(3):546-554. doi: 10.1038/eye.2017.231. Epub 2017 Nov 3.
- Background: PubMed 36272559Betzler BK, Putera I, Testi I, La Distia Nora R, Kempen J, Kon OM, Pavesio C, Gupta V, Agrawal R. Anti-tubercular therapy in the treatment of tubercular uveitis: A systematic review and meta-analysis. Surv Ophthalmol. 2023 Mar-Apr;68(2):241-256. doi: 10.1016/j.survophthal.2022.10.001. Epub 2022 Oct 19.
- Derived from this study: PubMed 41018498La Distia Nora R, Putera I, Riasanti M, Sitompul R, Edwar L, Susiyanti M, Aziza Y, Waliyuddin MZ, Widodo E, Sifyana UA, Jessica P, Ethelind R, Singh G, Dik WA, Rombach SM, van Hagen PM. Antitubercular therapy for uveitis of undetermined cause with positive interferon-gamma release assay: a single-blind, single-centre, phase 2 randomised controlled trial. EClinicalMedicine. 2025 Sep 17;88:103511. doi: 10.1016/j.eclinm.2025.103511. eCollection 2025 Oct.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rina La Distia Nora, MD, PhD principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti Tuberculosis Drug and Methylprednisolone in people with Tuberculous Uveitis, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Treatment Failure (time frame: 6 months after the initial therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05005637, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.