CompletedPhase 4

Six-months Versus Nine-months ATT for Ocular TB

Burma, India, Thailand58 participantsStarted 2020-01-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Non-recurrence of inflammation

Timeframe: One year after completion of ATT

Trial details

NCT IDNCT06613919

SponsorL.V. Prasad Eye Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

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