Health Condition 1: H359- Unspecified retinal disorder
Conditions
Interventions
Intervention1: Anti-TB Therapy: Majority of these studies have used adjunctive corticosteroids and/or immunosuppressants along with ATT.
Intervention2: 9 month of anti TB therapy: Ethambutol hydrochlo
Sponsors
Hyderabad Eye Resesarch Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1.Symptoms ï?£3 months Objective evidence of active intraocular inflammation compatible with TPU e.g. active retinal vasculitis (with FA leakage) or choroidal lesions 2. Positive results of tuberculin skin test (TST, ï?³10 mm induration after 48 hours with 5TU) and/or interferon gamma release assay (Quantiferon TB Gold or T-SPOT) 3. May have evidence of healed pulmonary or other TB (but not requiring ATT for that disease) 4. Age >18 years, not pregnant or willing to use double contraception
Exclusion criteria
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 1.Optic nerve involvement 2.Past history of uveitis 3.Previous ATT for ocular or other disease 4.Concurrent active pulmonary or other TB disease requiring ATT for that disease. 5.HIV infection and other immunocompromised patients 6.Treated with systemic or local corticosteroids within 3 months prior to entry 7.Received anti-VEGF injections within 3 months prior to entry 8.Age less than 18 years 9.Pregnancy 10.Liver disease 11.Likelihood of poor compliance/ refusal to participate in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure (using multicomponent inflammation outcomes including new choroidal/retinal lesions relative to baseline and/or vitritis ï?³grade 2) after completion of 6- or 9-month ATT. Recurrence of anterior uveitis or vitritis (grade 2) alone, without any active retinal or choroidal lesions will not be considered as treatment failure.Timepoint: after 9 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in BCVA from baseline after completion of ATT (at the end of 6- or 9-months) 2. Change in BCVA from baseline at final visit (one year after completion of ATT) 3. Need for additional medical treatment (topical prednisolone, IOP-lowering medications) 4. Need for additional surgical procedures (cataract, vitrectomy, glaucoma, intravitreal anti-VEGF injections) Timepoint: NIL | — |
Countries
India, Indonesia, Malaysia, Myanmar, Philippines, Saudi Arabia, South Africa, Thailand, Viet Nam
Contacts
Public ContactDr Soumyava Basu
L V Prasad Eye Institute
Outcome results
None listed