Uveitis accounts for 15% of the causes of legal blindness. The etiological diagnosis of uveitis is difficult because of the poor bacteriological performance of aqueous or vitreous fluid analysis. At the end of a medical and paramedical check-up, oriented by the typology of uveitis, a clinical situation is frequently encountered: idiopathic uveitis with a Quantiferon test (QFN) positive orienting to an old or recent contact with tuberculosis. Ocular tuberculosis is often characterized by a partial and transient response to corticosteroid therapy (local or general), due to predominant hypersensitivity phenomena and low inoculum. Therefore, antitubercular treatment is recommended for idiopathic posterior uveitis with positive QFN. This treatment of 6-9 months has shown, in combination with systemic corticosteroids, its effectiveness on ocular inflammation and significant decrease in recurrence frequency. For previous uveitis with QFN positive, there is no study or recommendation in the low endemic countries on the indication of anti-tuberculosis drugs and practices are variable. Tuberculous anterior uveitis is distinguished by high rate of relapses and chronic uveitis upon discontinuation of topic corticosteroid therapy that exposes to broad posterior synechiae leading to an ocular functional impairment. Optimizing the management of recurrent anterior uveitis is therefore crucial. The aim of this prospective, randomized, controlled, open, two parallel arm trial is to compared antitubercular treatment "add-on "of local corticosteroid therapy to Local Corticosteroid Therapy Only in patients with recurrent or chronic anterior uveitis. Primary outcome is the treatment succes defined as uveitis recovery at 3 months and the absence of recurrence at 18 months of follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Treatment of ocular inflammation by "antitubercular treatment " add-on "of local corticosteroid therapy" comprising: * RIFATER © (Isoniazid + Rifampicin + Pyrazinamide) + Ethambutol (13.5-20 mg / kg / day) for 2 months then RIFINAH © (Isoniazid + Rifampicin) for 4 months * associated with a treatment similar to the control group.
Ethambutol
RIFINAH ©
Success
Success is defined by uveitis recovery at 3 months and the absence of recurrence at 18 months of follow-up. The intensity of the ocular inflammation will be evaluated using the Standardization of Uveitis Nomenclature (SUN) classification (score of cellular Tyndall and "Flare" of the aqueous humor) Failure is therefore defined as failure to recovery at 3 months of anterior uveitis or recurrence at 18 months.
Time frame: at 18 months
Proportion of patients having developped neutropenia
Neutropenia will be defined as PNN less than 1000 mm3
Time frame: at 6 months
Proportion of patients having developped hepatitis with clinical signs
Hepatitis will be defined as hepatitis with clinical signs and ALT greater than 3 times the normal value
Time frame: at 6 months
Proportion of patients having developped severe hepatitis
Severe hepatitis will be defined will be defined as ALT greater than 5 times the normal value
Time frame: at 6 months
Proportion of patients having developped moderate or severe skin allergy
Time frame: at 6 months
Proportion of patients having developped neuritis or optic atrophy
Time frame: at 6 months
Proportion of patients having developped acute renal failure
Time frame: at 6 months
Proportion of patients having developped peripheral neuropathy
Time frame: at 6 months
Proportion of patients having developped other adverse effects
Time frame: at 6 months
Proportion of patients with recurrence
Time frame: between 3 months and 18 months
Prevalence of failure
Time frame: at 12 months post-treatment
Cumulative incidence of episodes of ocular inflammation
Time frame: at 18 months
Cumulative number of anterior uveitis episodes
Time frame: at 18 months
Tyndall score
Time frame: at 1 month
Flare's score
Time frame: at 1 month
Tyndall score
Time frame: at 2 months
Flare's score
Time frame: at 2 months
Tyndall score
Time frame: at 3 months
Flare's score
Time frame: at 3 months
Tyndall score
Time frame: at 6 months
Flare's score
Time frame: at 6 months
Tyndall score
Time frame: at 12 months
Flare's score
Time frame: at 12 months
Tyndall score
Time frame: at 15 months
Flare's score
Time frame: at 15 months
Tyndall score
Time frame: at 18 months
Flare's score
Time frame: at 18 months
Proportion of patients who developed or worsened a decrease in visual acuity
Time frame: at 18 months
Proportion of patients who developed or worsened a decrease in visual acuity
Time frame: at 3 months
Proportion of patients who developed or worsened a decrease in visual acuity
Time frame: at 6 months
Proportion of patients who developed or worsened a decrease in visual acuity
Time frame: at 12 months
Proportion of patients who developed or worsened a decrease in visual acuity
Time frame: at 15 months
Proportion of patients who developed or worsened broad posterior synechiae
Time frame: at 3 months
Proportion of patients who developed or worsened broad posterior synechiae
Time frame: at 6 months
Proportion of patients who developed or worsened broad posterior synechiae
Time frame: at 12 months
Proportion of patients who developed or worsened broad posterior synechiae
Time frame: at 15 months
Proportion of patients who developed a glaucoma
Time frame: at 18 months
Proportion of patients who developed a glaucoma
Time frame: at 3 months
Proportion of patients who developed a glaucoma
Time frame: at 6 months
Proportion of patients who developed a glaucoma
Time frame: at 12 months
Proportion of patients who developed a glaucoma
Time frame: at 15 months
Proportion of patients who developed a cataract
Time frame: at 18 months
Proportion of patients who developed a cataract
Time frame: at 3 months
Proportion of patients who developed a cataract
Time frame: at 6 months
Proportion of patients who developed a cataract
Time frame: at 12 months
Proportion of patients who developed a cataract
Time frame: at 15 months
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