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Treatment FOr Corticosteroid Dependent UveitiS

ConditionNon Infectious Uveitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

FOCUS is the first prospective randomized study comparing standard of care (mycophenolate mofetil) to adalimumab in recently active non infectious uveitis (NIU) with steroid dependency. There is no firm evidence or randomized trials that compared classical immunosuppressive compounds to biological agents; or identified the best treatment in this condition. The burden of NIU has been reduced with the use of immunosuppressive agents and biologics, raising the question of which of these compounds should be preferentially used in recently active NIU with steroid dependency.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide written, informed consent prior to the performance of any study-specific procedures

≥18 years of age

Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature [SUN] criteria) of posterior, or pan- uveitis confirmed by documented medical history

Active chorioretinal or retinal vascular lesion

Disqualifiers

Infectious uveitis, masquerade syndromes (idiopathic uveitis is permitted)

Isolated anterior uveitis

Monocular patient

Active tuberculosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adalimumab

    Drug

    Adalimumab (80mg at day 0, then 40mg/14 days from W1 to W35 subcutaneously)

  • Mycophenolate Mofetil

    Drug

    2 g/day orally for 36 weeks

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: AdalimumabExperimental treatment 1 intervention
Group B: Mycophenolate mofetilActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment failure rate

Treatment failure is defined by any of the following in at least one eye: * new active, inflammatory chorioretinal or retinal vascular lesions; * worsening of Best Corrected Visual Acuity (BCVA) by\>3 lines; Score from 20/10 (best vision) to 20/2400 (worst vision). * 2- step increase in anterior chamber cell grade and/or in vitreous haze relative to baseline. Anterior chamber cells scored from 0 (None) to 4+ (intense: fibrin or plastic aquerous) and Vitreous haze Scored from 0 (\<1 cell in field) to +4 (\>100 cells in field) * absence of steroid discontinuation between week 13 and week 19 (as per protocol) * or any additional immunosuppressive drug or injectable steroids

Time frame
At week 36

Secondary outcomes

1

Time to treatment failure

Time frame
Up to week 55
2

Best corrected visual acuity

Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).

Time frame
At week 4
3

Best corrected visual acuity

Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).

Time frame
At week 8
4

Best corrected visual acuity

Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).

Time frame
At week 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: