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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. Identifier: NCT03971279
Recruitment Status : Completed
First Posted : June 3, 2019
Last Update Posted : November 26, 2019
Information provided by (Responsible Party):
Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

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)

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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

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

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

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Recurrent VKH posterior uveitis

Exclusion Criteria:

  • retinal pathology, other causes of posterior uveitis

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 identifier (NCT number): NCT03971279

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United Arab Emirates
Abu Dhabi, United Arab Emirates
Sponsors and Collaborators
Benha University
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Principal Investigator: Tarek Elhamaky Benha university faculty of medicine , INMC
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Responsible Party: Tarek Roshdy mohamed Mahgoub ELhamaky, Lecturer of ophthalmology, Benha University 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:
Additional relevant MeSH terms:
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Uveitis, Posterior
Uveal Diseases
Eye Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents