Pre and post vitrectomy infliximab in Bechet's disease posterior uveitis
| ISRCTN | ISRCTN20489230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20489230 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/02/2017
- Registration date
- 27/02/2017
- Last edited
- 29/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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
Contact information
Scientific
1 Ibrahim Abo El Naga Street
Cairo
11727
Egypt
 ORCID ID |
0000-0003-2647-5883 |
|---|
Study information
| Study design | Prospective non-controlled interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | The effectiveness of pre and post operative infliximab in controlling Bechet's disease posterior uveitis in patients undergoing vitrectomy: a preliminary study |
| Study objectives | 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(s) | Local institutional ethics committee, 05/12/2013 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Infliximab |
| Primary outcome measure | 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 study start date | 01/02/2014 |
| Completion date | 31/01/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2014 |
| Date of final enrolment | 30/06/2015 |
Locations
Countries of recruitment
- Egypt
Study participating centre
11562
Egypt
Sponsor information
University/education
Faculty of Medicine
Kasr Aini Street
Cairo
11562
Egypt
| Phone | +20 (0)2365 4060 |
|---|---|
| culrela@kasralaiy.edu.eg | |
| Website | www.medicine.cu.edu.eg |
"ROR" |
https://ror.org/03q21mh05 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 28/02/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2017 | 29/01/2019 | Yes | No |
Editorial Notes
29/01/2019: Publication reference added
