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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03971279
Recruitment Status : Completed
First Posted : June 3, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Posterior Uveitis Drug: Dexamethasone Ophthalmic implant

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 Design
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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Efficacy of Dexamethasone Intravitreal Implant (Ozurdex®) in Treatment of Recurrent VKH Uveitis
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : November 22, 2019
Actual Study Completion Date : November 22, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: Dexamethasone Ophthalmic implant
    intravitreal injection of ozurdex implant
    Other Name: ozurdex implant

Outcome Measures
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Primary Outcome Measures :
  1. Best corrected visual acuity (BCVA) [ Time Frame: 2 years ]
    Change in BCVA


Secondary Outcome Measures :
  1. optical coherence tomography (OCT) foveal thickness [ Time Frame: 2 years ]
    changes in central foveal thickness


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
16 patient with VKH disease who have recurrent attacks of posterio uveitis
Criteria

Inclusion Criteria:

  • Recurrent VKH posterior uveitis

Exclusion Criteria:

  • retinal pathology, other causes of posterior uveitis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971279


Locations
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United Arab Emirates
INMC
Abu Dhabi, United Arab Emirates
Sponsors and Collaborators
Benha University
Investigators
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Principal Investigator: Tarek Elhamaky Benha university faculty of medicine , INMC
More Information
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Responsible Party: Tarek Roshdy mohamed Mahgoub ELhamaky, Lecturer of ophthalmology, Benha University
ClinicalTrials.gov Identifier: NCT03971279    
Other Study ID Numbers: hamaky2
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University:
dexamethasone;VKH
Additional relevant MeSH terms:
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Uveitis
Uveitis, Posterior
Uveal Diseases
Eye Diseases
Panuveitis
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents