Condition category
Eye Diseases
Date applied
21/02/2017
Date assigned
27/02/2017
Last edited
27/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Behçet's disease is a rare condition that results in inflammation of the blood vessels and tissues, including inflammation of the eyes. This study involves adult patients who have been diagnosed with Bechet’s disease with eye inflammation that is not responding to treatments such as immunosuppressant drugs, and have eye complications that require surgery. The drug infliximab has been used to treat many conditions related to immune system disorders with promising results, but the drug is still not considered in routine treatment in many countries due to the high cost of the drug and the need for further doses for a long period to prevent the disease from coming back. In countries without medical insurance programs, doctors therefore face a problem treating patients with eye inflammation that is not responding to treatment. The aim of this study is to find out whether infliximab treatment before and after surgery reduces the possible risks of surgery on an inflamed eye, and results in a longer disease-free period (remission) even after stopping the drug.

Who can participate?
Patients aged 18-60 with Bechet’s disease with severe eye inflammation and vision-threatening complications requiring surgery, and not responding to treatment, including immunosuppressants

What does the study involve?
All participants are treated with infliximab given directly into a vein, followed by an additional two cycles 2 weeks apart to give a total of three treatment cycles before the intended surgery, to be followed by another three cycles after surgery. The participants are followed-up for any disease activity for up to 6 months.

What are the possible benefits and risks of participating?
The participants may benefit from being treated with a highly effective and expensive medication that is not covered by their medical insurance in a completely free manner, with the possibility of reducing the daily doses of their current medications, reducing the impact of side effects. The risks are expected to be minimal, as they are related to infliximab side effects, which will be kept to a minimum through careful selection of participants and follow up.

Where is the study run from?
Cairo University (Egypt)

When is the study starting and how long is it expected to run for?
February 2014 to January 2016

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Heba El Gendy

Trial website

Contact information

Type

Scientific

Primary contact

Dr Heba El Gendy

ORCID ID

http://orcid.org/0000-0003-2647-5883

Contact details

1 Ibrahim Abo El Naga Street
Cairo
11727
Egypt

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effectiveness of pre and post operative infliximab in controlling Bechet's disease posterior uveitis in patients undergoing vitrectomy: a preliminary study

Acronym

Study hypothesis

1. The pre-operative infliximab can control the ocular inflammatory condition and decrease the risk of intra-operative and post-operative complications
2. The continued post-operative infliximab can induce a long disease remission period

Ethics approval

Local institutional ethics committee, 05/12/2013

Study design

Prospective non-controlled interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Bechet's disease posterior uveitis

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

Infliximab

Primary outcome measures

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 measures

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

Overall trial start date

01/02/2014

Overall trial end date

31/01/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

01/02/2014

Recruitment end date

30/06/2015

Locations

Countries of recruitment

Egypt

Trial participating centre

Cairo University
Faculty of Medicine
11562
Egypt

Sponsor information

Organisation

Cairo University

Sponsor details

Faculty of Medicine
Kasr Aini Street
Cairo
11562
Egypt
+20 (0)2365 4060
culrela@kasralaiy.edu.eg

Sponsor type

University/education

Website

www.medicine.cu.edu.eg

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing plan
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

28/02/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes