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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 14 December 2015
Main ID:  NCT02620618
Date of registration: 26/11/2015
Prospective Registration: No
Primary sponsor: Cairo University
Public title: Intravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical Study
Scientific title: Intravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical Study
Date of first enrolment: January 2013
Target sample size: 20
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02620618
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 1/Phase 2
Countries of recruitment
Contacts
Name:     Mahmoud Soliman, MD PhD
Address: 
Telephone:
Email:
Affiliation:  Cairo University
Key inclusion & exclusion criteria

Inclusion criteria:

Refractory posterior uveitis in patients with Behçet's disease.

Exclusion criteria:

1. Patients receiving or who had received systemic infliximab or other TNFa inhibitors

2. Patients with uncontrolled systemic Behçet

3. Patients who received previous intravitreal steroids (< 6 months)

4. Patients with severe media opacity

5. Patients with previous history of ocular surgery other than cataract surgery

6. Cataract surgery within the previous 6 months.



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Behçet's Disease
Uveitis
Intervention(s)
Drug: Intravitreal Infliximab
Primary Outcome(s)
Best Corrected Visual Acuity in logMAR [Time Frame: 18 weeks]
Central Foveal Thickness in microns by Optical Coherence Tomography [Time Frame: 18 weeks]
Electroretinogram a and b waves amplitudes in microvolts [Time Frame: 18 weeks]
Electroretinogram a and b waves implicit times in milliseconds [Time Frame: 18 weeks]
Vitritis severity graded 0-3 [Time Frame: 18 weeks]
Secondary Outcome(s)
Secondary ID(s)
Intravitreal Infliximab
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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