Pre and post vitrectomy infliximab in Bechet's disease posterior uveitis

• Register: ISRCTN
• Last refreshed on: 11 February 2019
• Main ID: ISRCTN20489230
• Date of registration: 27/02/2017
• Prospective Registration: No
• Primary sponsor: Cairo University
• Public title: Pre and post vitrectomy infliximab in Bechet's disease posterior uveitis
• Scientific title: The effectiveness of pre and post operative infliximab in controlling Bechet's disease posterior uveitis in patients undergoing vitrectomy: a preliminary study
• Date of first enrolment: 01/02/2014
• Target sample size: 30
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN20489230
• Study type: Interventional
• Study design: Prospective non-controlled interventional study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Egypt

Contacts

• Name: Heba El Gendy

Key inclusion & exclusion criteria

Inclusion criteria:
1. Bechet's disease persistent posterior uveitis not responding to systemic treatment
2. Eyes with dense persistent vitreous opacities
3. Eyes with epiretinal membranes
4. Persistent macular edema
5. Age 18-60 years

Exclusion criteria:
1. Patients with active infections
2. End-stage disease
3. Impaired liver function, leucopenia and thrombocytopenia
4. Patients receiving immunosuppressants other than corticosteroids at time of application of the drug


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Bechet's disease posterior uveitis
Eye Diseases

Intervention(s)

The drug infliximab was given in a dose of 5 mg/kg intravenous infusion over a three-hour period once every two weeks for 3 treatment sessions prior to the planned pars plana vitrectomy, after stoppage of other immunosuppressant drugs and keeping the patients on their pre-exposure daily doses of corticosteroids. All patients underwent vitrectomy operation, and vitreous opacities as well as epiretinal and retinal membranes were managed accordingly. The drug infliximab was then given in a dose of 5 mg/kg intravenous infusion once every two weeks for 3 treatment sessions after the surgical intervention. Patients were observed for 1 hour after stopping infusion for adverse effects. Infusions were followed by maintenance treatment of oral prednisone, that was tapered accordingly. No patients were treated with topical steroids, or retrobulbar steroid injections. All patients were followed up for a period up to 6 months following the last treatment cycle.

Primary Outcome(s)

The improvement of ocular inflammatory reaction in response to the drug used, monitored clinically (i.e. improvement in ocular pain, improvement of the visual acuity measured in Log MAR, improvement in anterior chamber flare and cells, improvement in vitreous cells), measured before the initiation of each new treatment cycle (every 2 weeks), as well as during the follow-up periods (monthly after stopping of the drug infliximab at the last session, for a 6-month period)

Secondary Outcome(s)

1. Reduction in concomitant corticosteroids requirements (average daily dose), as the doses are gradually tapered once improvement of ocular inflammatory reaction is achieved and continued reduction based on the patient’s response reaching the minimum daily dose sufficient to maintain quite eye with no active inflammatory reaction.
2. The occurrence of disease reactivation (relapses), where disease activity is defined as cells and flare in the anterior chamber, vitreous cells, retinal perivascular sheathing, retinal infiltration, new retinal hemorrhages or optic papillitis, monitored on a monthly basis after stopping of the drug infliximab for a total period of 6 months after the last treatment cycle

Secondary ID(s)

N/A

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

Local institutional ethics committee, 05/12/2013

Results

• Results available: Yes
• Date Completed: 31/01/2016