Uveitis, AnteriorPhase 3URBANCT04117698
Multicenter, Randomized Study Evaluating the Value of Antitubercular Treatment During Recurent Anterior Uveitis (URBA)
A Phase 3 study testing Antitubercular treatment (RIFATER ©), Ethambutol and RIFINAH © in people with Uveitis, Anterior, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Anterior
- What is being tested?
- Antitubercular treatment (RIFATER ©), Ethambutol and RIFINAH ©
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years.
- For women of childbearing age (unless confirmed postmenopausal or sterile), βHCG negative.
- For subjects of childbearing age, the willingness to use adequate contraceptive measures to prevent the subject or partner of the subject from becoming pregnant during the first 6 months of the study in case of randomization in the experimental group.
- Recurrent anterior Uveitis (≥ 2 episodes of ocular inflammation within the past 2 years before inclusion with a free-interval of at least 3 months between ocular inflammations, patients with a second episode of ocular inflammation may be included in the study) or chronic anterior Uveitis (persistence of ocular inflammation = partial response after 3 months of well-conducted local treatment) .
- Positive Quantiferon test (QFN) performed after the first episode of ocular inflammation (accepted tests: Quantiferon-TB-Gold, Quantiferon-TB-Gold in tube or Quantiferon plus) with a threshold ≥ 1 IU / ml or associated with a positive ELISPOT test if the QFN level is between 0.7 and 1UI / l.
- Absence of other etiology that may explain anterior uveitis during etiological investigations
Show all 17Show fewer
- Serology of herpes group viruses (HSV,, CMV, VZV) negative or old immunity (achieved after the first episode of ocular inflammation).
- TPHA, negative VDRL (performed after the 1st episode of ocular inflammation).
- Serologies HIV, HBV and HCV, negative (performed within the 3 months before inclusion).
- Negative Lyme serology (performed after the first episode of ocular inflammation) or medical history not supporting this etiology
- HLA B27 negative (achieved after the first episode of ocular inflammation) if recurrent or non-granulomatous uveitis
- Negative PCR from anterior chamber fluid for Herpes group viruses, Toxoplasma gondii and Mycobacterium tuberculosis if severe inflammation (Tyndall Cellular and / or Flare> 2+) and / or posterior synechiae .
- Non-contributory pulmonary imaging (performed within the last month before inclusion) (radiography or chest CT scan left to the discretion of the clinician).
- Note: The non-granulomatous character uveitis during clinical examination is not an exclusion criterion.
- If 4+ severity score (Tyndall and / or Flare of aqueous humor) an expert opinion is required (internist / ophthalmologist pair): with no indication to initiate an anti-tuberculosis treatment without delay.
- Signature of informed consent to participate in the study.
- Patients affiliated to the French health care insurance
Who cannot join
- Weight strictly less than 50 kg
- Weight strictly greater than 185 kg
- History of cancer 5 years before inclusion (except in situ cervical cancer or non-metastatic baso or squamous cell carcinoma) or progressive malignant hemopathy.
- Liver failure or ALTgreater than three times the normal value or severe renal impairment (GFR <30ml / min).
- Neutropenia <1000 / mm3, Thrombocytopenia <50,000 / mm3, Hemoglobin <8g / dL
- Pulmonary or active visceral tuberculosis.
Show all 33Show fewer
- Associated posterior and intermediate uveitis (indication for almost constant systemic corticosteroid therapy, and de facto contraindication to a control arm without TB treatment).
- Monophthalmic patient
- Intervention with general anesthesia during the first 6 months
- Clinical presentation of acute anterior uveitis type HLA B27.
- History of tuberculous disease treated.
- Systemic corticosteroid therapy or immunosuppressive therapy received within 3 months before inclusion.
- Local corticotherapy received for more than 15 days in the 2 months before inclusion.
- Hypersensitivity to the family of rifamycin, isoniazid, pyrazinamide and known ethambutol or to any of the excipients present in the medicinal products of this trial (presence, in particular, of excipients with known effect: sucrose, sodium)
- Known hypersensitivity to fluorometholone or any of the excipients, in particular with benzalkonium chloride.
- Known hypersensitivity to dexamethasone phosphate or to any of the excipients
- Known hypersensitivity to tropicamide, atropine or its derivatives,
- Known hypersensitivity to phenylephrine, thiomersal
- Antecedent of optic neuritis.
- Patients with wheat allergy (other than celiac disease).
- Association with praziquantel, voriconazole, which cannot be interrupted for clinical research study.
- Porphyries known.
- Patient under Valaciclovir
- Hyperuricemic subjects with symptomatic joint involvement
- Eye infections not controlled by antiinfectives, such as:
- acute purulent bacterial infections, including Pseudomonas and Mycobacteria infections,
- fungal infections,
- epithelial keratitis due to Herpes simplex virus (dendritic keratitis), vaccinia virus, varicella zoster virus and most other viral infections of the cornea and conjunctiva,
- amoebic keratitis,
- Perforation, ulceration and corneal injury associated with incomplete reepithelialization
- Known ocular hypertension caused by glucocorticoids, risk of angle closure glaucoma,
- Pregnancy or breastfeeding.
- Psychiatric disorder and / or patient under guardianship.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
- Conditions
- Uveitis, Anterior
- Being tested
- Antitubercular treatment (RIFATER ©), Ethambutol, RIFINAH ©
- Medical subject headings
- Uveitis, Anterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antitubercular treatment (RIFATER ©)Drug
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.
EthambutolDrug
Ethambutol
RIFINAH ©Drug
RIFINAH ©
| Study group | Role | What they receive |
|---|---|---|
| Antitubercular treatment and local corticosteroid therapy | Experimental | 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. Receives: Drug: Antitubercular treatment (RIFATER ©); Drug: Ethambutol; Drug: RIFINAH © |
| Local Corticosteroid Therapy Only | No intervention | Treatment of Ocular Inflammation by "Local Corticosteroid Therapy Only" comprising: * Dexamethasone (DEXAFREE® eye drops) at an attack dose for one week (4 to 6 drops / d maximum and if severe inflammation 1 drop / hour) then decrease and stop over 3 weeks, with relay by fluorometholone (Flucon®) for 2 months maximum. The modalities of the decrease of the local steroids are left to the ophthalmologists own judgment. Maximum total duration of 3 months. * Mydriatic (tropicamide) 1gx3 / d if necessary. * Neosynephrine 5% if posterior synechiae. * Atropine (Alcon 0.3%) if pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 18 months
Secondary outcomes (45)
Proportion of patients having developped neutropenia
Neutropenia will be defined as PNN less than 1000 mm3
Measured: 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
Measured: 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
Measured: at 6 months
Proportion of patients having developped moderate or severe skin allergy
Measured: at 6 months
Proportion of patients having developped neuritis or optic atrophy
Measured: at 6 months
Proportion of patients having developped acute renal failure
Measured: at 6 months
Proportion of patients having developped peripheral neuropathy
Measured: at 6 months
Proportion of patients having developped other adverse effects
Measured: at 6 months
Proportion of patients with recurrence
Measured: between 3 months and 18 months
Prevalence of failure
Measured: at 12 months post-treatment
Cumulative incidence of episodes of ocular inflammation
Measured: at 18 months
Cumulative number of anterior uveitis episodes
Measured: at 18 months
Tyndall score
Measured: at 1 month
Flare's score
Measured: at 1 month
Tyndall score
Measured: at 2 months
Flare's score
Measured: at 2 months
Tyndall score
Measured: at 3 months
Flare's score
Measured: at 3 months
Tyndall score
Measured: at 6 months
Flare's score
Measured: at 6 months
Tyndall score
Measured: at 12 months
Flare's score
Measured: at 12 months
Tyndall score
Measured: at 15 months
Flare's score
Measured: at 15 months
Tyndall score
Measured: at 18 months
Flare's score
Measured: at 18 months
Proportion of patients who developed or worsened a decrease in visual acuity
Measured: at 18 months
Proportion of patients who developed or worsened a decrease in visual acuity
Measured: at 3 months
Proportion of patients who developed or worsened a decrease in visual acuity
Measured: at 6 months
Proportion of patients who developed or worsened a decrease in visual acuity
Measured: at 12 months
Proportion of patients who developed or worsened a decrease in visual acuity
Measured: at 15 months
Proportion of patients who developed or worsened broad posterior synechiae
Measured: at 3 months
Proportion of patients who developed or worsened broad posterior synechiae
Measured: at 6 months
Proportion of patients who developed or worsened broad posterior synechiae
Measured: at 12 months
Proportion of patients who developed or worsened broad posterior synechiae
Measured: at 15 months
Proportion of patients who developed a glaucoma
Measured: at 18 months
Proportion of patients who developed a glaucoma
Measured: at 3 months
Proportion of patients who developed a glaucoma
Measured: at 6 months
Proportion of patients who developed a glaucoma
Measured: at 12 months
Proportion of patients who developed a glaucoma
Measured: at 15 months
Proportion of patients who developed a cataract
Measured: at 18 months
Proportion of patients who developed a cataract
Measured: at 3 months
Proportion of patients who developed a cataract
Measured: at 6 months
Proportion of patients who developed a cataract
Measured: at 12 months
Proportion of patients who developed a cataract
Measured: at 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, AnteriorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117698
- Sponsor's protocol ID
- P160912J
- Acronym
- URBA
- Status last verified
- Oct 2019
- First submitted
- 3 Oct 2019
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized Study Evaluating the Value of Antitubercular Treatment During Recurent Anterior Uveitis (URBA)
- ClinicalTrials.gov ID
- NCT04117698
- Acronym / sponsor ID
- URBA / P160912J
- Conditions
- Uveitis, Anterior
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antitubercular treatment and local corticosteroid therapy | Experimental | Drug: Antitubercular treatment (RIFATER ©), Drug: Ethambutol, Drug: RIFINAH ©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. |
| Local Corticosteroid Therapy Only | No intervention | –Treatment of Ocular Inflammation by "Local Corticosteroid Therapy Only" comprising: * Dexamethasone (DEXAFREE® eye drops) at an attack dose for one week (4 to 6 drops / d maximum and if severe inflammation 1 drop / hour) then decrease and stop over 3 weeks, with relay by fluorometholone (Flucon®) for 2 months maximum. The modalities of the decrease of the local steroids are left to the ophthalmologists own judgment. Maximum total duration of 3 months. * Mydriatic (tropicamide) 1gx3 / d if necessary. * Neosynephrine 5% if posterior synechiae. * Atropine (Alcon 0.3%) if pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age≥18 years.
- For women of childbearing age (unless confirmed postmenopausal or sterile), βHCG negative.
- For subjects of childbearing age, the willingness to use adequate contraceptive measures to prevent the subject or partner of the subject from becoming pregnant during the first 6 months of the study in case of randomization in the experimental group.
- Recurrent anterior Uveitis (≥ 2 episodes of ocular inflammation within the past 2 years before inclusion with a free-interval of at least 3 months between ocular inflammations, patients with a second episode of ocular inflammation may be included in the study) or chronic anterior Uveitis (persistence of ocular inflammation = partial response after 3 months of well-conducted local treatment) .
- Positive Quantiferon test (QFN) performed after the first episode of ocular inflammation (accepted tests: Quantiferon-TB-Gold, Quantiferon-TB-Gold in tube or Quantiferon plus) with a threshold ≥ 1 IU / ml or associated with a positive ELISPOT test if the QFN level is between 0.7 and 1UI / l.
Key exclusion criteria (33 listed)
- Weight strictly less than 50 kg
- Weight strictly greater than 185 kg
- History of cancer 5 years before inclusion (except in situ cervical cancer or non-metastatic baso or squamous cell carcinoma) or progressive malignant hemopathy.
- Liver failure or ALTgreater than three times the normal value or severe renal impairment (GFR <30ml / min).
- Neutropenia <1000 / mm3, Thrombocytopenia <50,000 / mm3, Hemoglobin <8g / dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antitubercular treatment (RIFATER ©)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. | Drug | Antitubercular treatment and local corticosteroid therapy |
| EthambutolEthambutol | Drug | Antitubercular treatment and local corticosteroid therapy |
| RIFINAH ©RIFINAH © | Drug | Antitubercular treatment and local corticosteroid therapy |
Primary outcome
Success
Time frame: at 18 months
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.
45 secondary outcomes
Proportion of patients having developped neutropenia
Time frame: at 6 months
Proportion of patients having developped hepatitis with clinical signs
Time frame: at 6 months
Proportion of patients having developped severe hepatitis
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Uveitis, Anterior
RecruitingPhase 2
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU
Active Non-anterior, Non-infectious Uveitis
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Not yet recruitingPhase 2
Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
Behçet's Syndrome, Behçet's Syndrome (BS)
RecruitingPhase 2
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
Behcet Syndrome, Intestinal Type
RecruitingObservational study
PANDA-ASOCT: Paediatric Anterior Uveitis Detection With Automated Image Analysis Using ASOCT
Uveitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antitubercular treatment (RIFATER ©), Ethambutol and RIFINAH © in people with Uveitis, Anterior, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georges Sélim TRAD (+33149095642, salim.trad@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success (time frame: at 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.