Uveitis Clinical Trial
Official title:
Outcome of Treatment of Uveitis With Biologic Drugs in Resistant Cases Vogt-koyanagi-Harada Disease
NCT number | NCT05349747 |
Other study ID # | Uveitis |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 30, 2022 |
Est. completion date | August 2024 |
- Reviewing the characteristics of patients with uveitis caused by Vogt-Koyanagi-Harada Syndrome treated at Assiut University Hospital at the Department of Ophthalmology and Department of Rheumatology, Physical Medicine, and Rehabilitation including the ocular features in terms of uveitis location, type and complications and systemic features of those subjects who showed an inadequate response to conventional immunomodulatory drugs. - Assess the results of treatment with biologic drugs, including rates of failure and adverse events. This will help uveitis specialists to reach a conclusion about the best treatment protocols for Uveitis in Vogt-Koyanagi-Harada Syndrome in our population in terms of safety, efficacy, and cost-effectiveness.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | August 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Uveitis with clinical features of Vogt-Koyanaga-Harada Syndrome. 2. A follow-up and assessment at least twelve months from the start of treatment. Exclusion Criteria: - Exclusion of other infectious and non-infectious uveiticuveitis etiologies that may mimic the given clinical presentation of autoimmune uveitis; - The presence of contraindication to treatment with biologic drugs e.g. active or latent tuberculosis, viral hepatitis and demyelinating diseases. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
Fang W, Yang P. Vogt-koyanagi-harada syndrome. Curr Eye Res. 2008 Jul;33(7):517-23. doi: 10.1080/02713680802233968. Review. Erratum in: Curr Eye Res. 2008 Sep;33(9):812.. — View Citation
Hatemi G, Christensen R, Bang D, Bodaghi B, Celik AF, Fortune F, Gaudric J, Gul A, Kötter I, Leccese P, Mahr A, Moots R, Ozguler Y, Richter J, Saadoun D, Salvarani C, Scuderi F, Sfikakis PP, Siva A, Stanford M, Tugal-Tutkun I, West R, Yurdakul S, Olivieri I, Yazici H. 2018 update of the EULAR recommendations for the management of Behçet's syndrome. Ann Rheum Dis. 2018 Jun;77(6):808-818. doi: 10.1136/annrheumdis-2018-213225. Epub 2018 Apr 6. — View Citation
Imrie FR, Dick AD. Biologics in the treatment of uveitis. Curr Opin Ophthalmol. 2007 Nov;18(6):481-6. Review. — View Citation
Pasadhika S, Rosenbaum JT. Update on the use of systemic biologic agents in the treatment of noninfectious uveitis. Biologics. 2014 Feb 15;8:67-81. doi: 10.2147/BTT.S41477. eCollection 2014. Review. — View Citation
Rubsamen PE, Gass JD. Vogt-Koyanagi-Harada syndrome. Clinical course, therapy, and long-term visual outcome. Arch Ophthalmol. 1991 May;109(5):682-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | non-resolution of inflammation, or failure of complete clinical resolution of the primary lesion in cases of retinitis or choroiditis. | Prospective | at 6 month | |
Primary | Recurrence of inflammation described as a two-step increase in inflammation as defined by the SUN working group criteria for anterior and intermediate uveitis | prospective | at 6 month | |
Secondary | non-resolution of inflammation, or failure of complete clinical resolution of the primary lesion in cases of retinitis or choroiditis. | prospective | at 12 month | |
Secondary | Recurrence of inflammation described as a two-step increase in inflammation as defined by the SUN working group criteria for anterior and intermediate uveitis | prospective | at 12 month |
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