Dexamethasone Intravitreal Implant (Ozurdex®) for Recurrent Vogt-Koyanagi-Harada (VKH) Disease Posterior Uveitis

November 24, 2019 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

Long Term Efficacy of Dexamethasone Intravitreal Implant (Ozurdex®) in Treatment of Recurrent VKH Uveitis

VKH disease is a vision threatening condition.The investigators consider that ozurdex intravitreal implant is an effective line of treatment in recurrent VKH posterior uveitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Baseline ,and postoperative 1 ,6 ,12 and 24 months full ophthalmic examination was done.

Procedure included intravitreal injection of Dexamethasone implant 0.7 mg (Ozurdex(®); Allergan, Inc, Irvine, CA)

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

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

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

16 patient with VKH disease who have recurrent attacks of posterio uveitis

Description

Inclusion Criteria:

  • Recurrent VKH posterior uveitis

Exclusion Criteria:

  • retinal pathology, other causes of posterior uveitis

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: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity (BCVA)
Time Frame: 2 years
Change in BCVA
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
optical coherence tomography (OCT) foveal thickness
Time Frame: 2 years
changes in central foveal thickness
2 years

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Principal Investigator: Tarek Elhamaky, Benha university faculty of medicine , INMC

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 (Actual)

January 1, 2017

Primary Completion (Actual)

November 22, 2019

Study Completion (Actual)

November 22, 2019

Study Registration Dates

First Submitted

May 30, 2019

First Submitted That Met QC Criteria

May 31, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 24, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hamaky2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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