Six-months Versus Nine-months ATT for Ocular TB

NCT06613919 | Completed Phase 4

• 1 other identifier: 2019-011-BHR-29
• Study Type: interventional
• Target: 58
• Locations: 3 countries
• Sites: 3

Brief Summary

The goal of this clinical trial is to learn if 6-months anti-TB therapy is not worse than 9-months therapy for the treatment of tubercular posterior uveitis. The main questions it aims to answer are: Does six-month therapy work as well as the nine-month therapy? Do any of the specific phenotypes of TB posterior uveitis respond better to any specific duration of anti-TB therapy? Participants: Took the standard dose of six- or nine-month ATT for TB posterior uveitis Visit the clinic as advised for checkups and tests

Conditions

Tuberculosis (TB); Uveitis; Retinal Vasculitis; Choroiditis

Keywords

Tuberculosis; Uveitis; anti-TB therapy; duration

Outcome Measures

Primary Outcomes (1)

• Non-recurrence of inflammation

  Treatment failure after completion of 6- or 9-month ATT.

  One year after completion of ATT

Study Arms (2)

Six months

EXPERIMENTAL

Six months anti-TB therapy

Drug: Anti-Tuberculosis Treatment

Nine months

ACTIVE COMPARATOR

Nine months anti-TB therapy

Drug: Anti-Tuberculosis Treatment

Interventions

Anti-Tuberculosis Treatment DRUG

Standard, weight adjusted anti-TB therapy for six months

Six months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Objective evidence of active intraocular inflammation compatible with TPU e.g. active retinal vasculitis (with FA leakage) or choroidal lesions
• Positive results of tuberculin skin test (TST \>=10 mm induration after 48 hours with 5TU) and/or interferon gamma release assay (Quantiferon TB Gold or T-SPOT)
• May have evidence of healed pulmonary or other TB (but not requiring ATT for that disease)
• Age more than 18 years, not pregnant

You may not qualify if:

• Ophthalmic findings or ancillary test results consistent with non-TB diagnosis
• Objective findings showing only non-active disease eg. occluded retinal vessels only, with no FA leakage from non-occluded vessels, or atrophic/scarred choroidal lesions
• Optic nerve involvement
• Past history of uveitis
• Previous ATT for ocular or other disease
• Concurrent active pulmonary or other TB disease requiring ATT for that disease.
• HIV infection and other immunocompromised patients
• Treated with systemic or local corticosteroids within 3 months prior to entry
• Received anti-VEGF injections within 3 months prior to entry
• Age \<18 years
• Pregnancy
• Liver disease
• Likelihood of poor compliance/ refusal to participate in study

Sponsors & Collaborators

• L.V. Prasad Eye Institute: lead

Study Sites (3)

University of Medicine Magway, EENT Hospital

Nay Pyi Taw, Burma

Location

LV Prasad Eye Institute

Bhubaneswar, Odisha, 751034, India

Location

Ramathibodi Hospital, Mahidol University

Bangkok, Thailand

Location

Related Publications (2)

• Nunn AJ, Phillips PP, Mitchison DA. Timing of relapse in short-course chemotherapy trials for tuberculosis. Int J Tuberc Lung Dis. 2010 Feb;14(2):241-2.

  PMID: 20074418 BACKGROUND

• Kee AR, Gonzalez-Lopez JJ, Al-Hity A, Gupta B, Lee CS, Gunasekeran DV, Jayabalan N, Grant R, Kon OM, Gupta V, Westcott M, Pavesio C, Agrawal R. Anti-tubercular therapy for intraocular tuberculosis: A systematic review and meta-analysis. Surv Ophthalmol. 2016 Sep-Oct;61(5):628-53. doi: 10.1016/j.survophthal.2016.03.001. Epub 2016 Mar 10.

  PMID: 26970263 BACKGROUND

MeSH Terms

Conditions

Tuberculosis; Uveitis; Retinal Vasculitis; Choroiditis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Uveal Diseases; Eye Diseases; Retinal Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Choroid Diseases; Uveitis, Posterior; Panuveitis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Uveitis Services

Model Details: Non-inferiority trial

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1); BU (1); IN (1)