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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 December 2015 |
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Main ID: |
NCT02620618 |
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Date of registration:
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26/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical Study
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Scientific title:
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Intravitreal Infliximab in Refractory Uveitis in Behcet's Disease: A Safety and Efficacy Clinical Study |
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Date of first enrolment:
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January 2013 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02620618 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Contacts
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Name:
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Mahmoud Soliman, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Behçet's Disease
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Uveitis
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Intervention(s)
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Drug: Intravitreal Infliximab
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Primary Outcome(s)
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Best Corrected Visual Acuity in logMAR
[Time Frame: 18 weeks]
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Electroretinogram a and b waves amplitudes in microvolts
[Time Frame: 18 weeks]
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Vitritis severity graded 0-3
[Time Frame: 18 weeks]
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Electroretinogram a and b waves implicit times in milliseconds
[Time Frame: 18 weeks]
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Central Foveal Thickness in microns by Optical Coherence Tomography
[Time Frame: 18 weeks]
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Secondary ID(s)
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Intravitreal Infliximab
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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