Outcome of Treatment of Uveitis With Biologic Drugs in Resistant Cases Vogt-koyanagi-Harada Disease

NCT05349747 | Unknown

• 1 other identifier: Uveitis
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

• 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.

Conditions

Uveitis

Outcome Measures

Primary Outcomes (2)

• non-resolution of inflammation, or failure of complete clinical resolution of the primary lesion in cases of retinitis or choroiditis.

  Prospective

  at 6 month

• 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 Outcomes (2)

• non-resolution of inflammation, or failure of complete clinical resolution of the primary lesion in cases of retinitis or choroiditis.

  at 12 month

• Recurrence of inflammation described as a two-step increase in inflammation as defined by the SUN working group criteria for anterior and intermediate uveitis

  at 12 month

Interventions

Biologic drugs BIOLOGICAL

Assess the results of treatment with biologic drugs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Uveitis with clinical features of Vogt-Koyanaga-Harada Syndrome.

You may qualify if:

• Uveitis with clinical features of Vogt-Koyanaga-Harada Syndrome.
• A follow-up and assessment at least twelve months from the start of treatment.

You may not qualify if:

• The presence of contraindication to treatment with biologic drugs e.g. active or latent tuberculosis, viral hepatitis and demyelinating diseases.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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.

  PMID: 24600203 BACKGROUND

• Fang W, Yang P. Vogt-koyanagi-harada syndrome. Curr Eye Res. 2008 Jul;33(7):517-23. doi: 10.1080/02713680802233968.

  PMID: 18600484 BACKGROUND

• Rubsamen PE, Gass JD. Vogt-Koyanagi-Harada syndrome. Clinical course, therapy, and long-term visual outcome. Arch Ophthalmol. 1991 May;109(5):682-7. doi: 10.1001/archopht.1991.01080050096037.

  PMID: 2025171 BACKGROUND

• Imrie FR, Dick AD. Biologics in the treatment of uveitis. Curr Opin Ophthalmol. 2007 Nov;18(6):481-6. doi: 10.1097/ICU.0b013e3282f03d42.

  PMID: 18163000 BACKGROUND

• Hatemi G, Christensen R, Bang D, Bodaghi B, Celik AF, Fortune F, Gaudric J, Gul A, Kotter 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 Behcet's syndrome. Ann Rheum Dis. 2018 Jun;77(6):808-818. doi: 10.1136/annrheumdis-2018-213225. Epub 2018 Apr 6.

  PMID: 29625968 BACKGROUND

MeSH Terms

Conditions

Uveitis

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Salma Safwat, Master

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

salma Safwat

CONTACT

+201022691820; Salmahafez91@outlook.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 27, 2022
• Study Start: April 30, 2022
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share