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

April 21, 2022 updated by: Salma Safwat Abdelhady Hafez, Assiut University
  • 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Uvea (Latin for grape) is the middle vascular coat of the eyeball. Strictly speaking, uveitis is defined as inflammation of the uvea, but often the inflammatory process involves adjacent intraocular structures e.g. the anterior chamber, the vitreous humor, or the retina. Inflammation in the uvea can be due to infections, masquerades such as B-cell lymphoma, or immune-mediated diseases.

Vogt-Koyanagi-Harada syndrome is a systemic autoimmune disease characterized by bilateral, chronic, diffuse granulomatous panuveitis in addition to neurological, auditory, and integumentary manifestations. These manifestations are variable and race dependent.

This inflammatory syndrome is probably the result of an autoimmune mechanism, influenced by genetic factors, and appears to be directed against melanocytes. On histopathologic examination, typical cases show non-necrotizing diffuse granulomatous panuveitis with initial sparing and late involvement of the choriocapillaris and formation of Dalen-Fuchs' nodules. Fluorescein angiography, lumbar puncture, and echography are useful adjuncts in the diagnosis and management of VKH syndrome. Patients with this syndrome are treated generally with high dose systemic corticosteroids, immunomodulatory agents such as cyclosporine, or more recently biological response modifiers which are used as steroid-sparing agents to minizeminimize side effects of long term steroid use.

Since their discovery in the 1990s, biologic drugs have been used to treat uveitis refractory to traditional immunosuppressants. Many questions on their use though have remained unanswered; particularly when to initiate therapy, which agent and at what dosage to use, and for how long the treatment should continue.

The Biologic Response Modifiers represent the future of therapy in immune-mediated uveitis. Biological anti-inflammatory agents (for example antagonists of tumor necrosis factor alpha-like Infliximab and adalimumab) are also showing very promising results.

Biologics alone or combined with conventional therapies are used in refractory cases of Uveitis. Biologics reported for use in uveitis interferon alpha 2a (IFN-α 2a); anti-tumor necrosis factor (TNF) agents-infliximab and adalimumab; anti-interleukins (IL)-tocilizumab, secukinumab (in most of the published papers, this biologic has failed to demonstrate the ability to control uveitis when compared to placebo) and gevokizumab; anti-CD20-rituximab and anti-CD 25-daclizumab.

In many cases, these agents will be seen listed as the first choice in some autoimmune diseases, depending on the patient's history, age, sex, type and severity of the inflammatory disease, etc. The interdisciplinary treatment between ophthalmologists and rheumatologist is essential to initiate and monitor these therapies. Follow-up visits of subjects with uveitis should be aimed to determine the evolution of inflammatory signs until their complete resolution, thus ensuring the least possible consequences.

The most common side effects are localized site reactions (pain, erythema, and rash). other side effects include upper respiratory tract infections, urinary tract infections, cough, rash, back pain, nausea, vomiting, abdominal pain, headache, weakness, and fever. Other noted side effects include low or high blood pressure, chest pain, difficulty breathing, rash, itching, fever, and chills.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
non-resolution of inflammation, or failure of complete clinical resolution of the primary lesion in cases of retinitis or choroiditis.
Time Frame: at 6 month
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
Time Frame: at 6 month
prospective
at 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
non-resolution of inflammation, or failure of complete clinical resolution of the primary lesion in cases of retinitis or choroiditis.
Time Frame: at 12 month
prospective
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
Time Frame: at 12 month
prospective
at 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Salma Safwat, Master, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 30, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uveitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uveitis

Clinical Trials on Biologic drugs

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe