Proportion of Clinical Improvement & Type 1 Interferon (IFN) Score Changes in Idiopathic Uveitis Patients With Interferon Gamma Release Assay (IGRA) Positive

Launched by FAKULTAS KEDOKTERAN UNIVERSITAS INDONESIA · Sep 11, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring how well patients with a specific eye condition called idiopathic uveitis respond to a treatment for tuberculosis, especially when they have tested positive for a certain test (IGRA). The researchers want to see if this treatment can lead to improvements in their eye condition and if there are changes in specific biological markers in their blood. By understanding these effects, the study aims to find out who might benefit from this treatment.

To be part of this study, participants must be at least 18 years old, have idiopathic uveitis with a positive IGRA test, and should not have active tuberculosis or have taken tuberculosis treatment before. They should also have signs of eye inflammation. Participants will be monitored before and after receiving the treatment and will have their health checked regularly. This research is crucial for determining the best ways to help patients with this eye condition and improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• Subjects who will be recruited to this study are patients who met the criteria described below:
• • Registered patients from September 2019 at Cipto Mangunkusumo Hospital
• • Idiopathic uveitis patients (proven having negative result by available etiological uveitis work-ups) with IGRA positive. IGRA positive value is defined by score above 0.35 u/ml obtained from Quantiferon Tuberculosis (QFT)-Gold Assay (QIAGEN).
• • Minimum age: 18 years old
• • Proven not having active Tuberculosis
• • Not previously received Anti Tuberculosis Therapy.
• • Not consuming antibiotic one to two weeks prior to the time of study
• • Not living together with Tuberculosis active patient
• • Not having plan to become pregnant during the time of study
• • Not part of reactive Tuberculosis risk group based on Latent Tuberculosis Incident WHO guidelines 2018
• • Active inflammation in the past 180 days characterized by the following sign based on SUN Criteria(in at least one eye)
• • ≥ 2+ anterior chamber cells
• • ≥ 2+ vitreous haze
• • active retinal or choroidal lesions
• • Active inflammation during patient registration, characterized by the following sign based on SUN Criteria (in at least one eye)
• • ≥1+ anterior chamber cells and/or
• • ≥1+ vitreous haze and/or
• • active retinal/choroidal lesions
• Exclusion Criteria:
• • Not willing to sign informed consent
• • Pregnant patient
• • Not coming to scheduled visit date
• • Uveitis caused by infectious origin
• • Media opacity caused by cataract and/ or corneal scar resulting in difficulty of posterior segment examination in both eyes
• • Chronic hypotony (IOP \< 5 mm Hg for \> 3 months) in both eyes
• • History of prior intraocular surgery in \< 30 days, or arranged surgery within the next 6 months
• • Best spectacle-corrected visual acuity (BSCVA) of hand motions or worse in better eye
• • Any history of cancer excluding non-melanoma skin cancer
• • Abnormal Complete blood count (≤ 2,500 white blood cells and/or ≤ 75,000 platelets and/or ≤9 hemoglobin) within 4 weeks prior to enrollment\^
• • Abnormal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal for the lab and/or creatinine ≥ 1.5 within 4 weeks prior to enrollment\^
• • Patient with active infection of tuberculosis, HIV infection, syphilis, or hepatitis B or C
• • Note (\^): Testing is conducted within 1-2 weeks prior to enrollment;
• As many 10 subjects of the health volunteers are recruited for this study after giving consent. The health volunteers that will be recruited are the subject who met following criteria:
• • 1. age: 18-50 years old (Man/Woman)
• • 2. not having any health complaint or symptoms
• • 3. not in any long term medication
• • 4. body mass index: 18.5 - \< 30
• • 5. no history of allergy
• • 6. willing to cooperate in this study
• • 7. state of complete physical, mental, and social well being, and not merely the absence of disease or infirmity (WHO healthy definition)