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

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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

Tracking Information
First Submitted Date May 30, 2019
First Posted Date June 3, 2019
Last Update Posted Date November 26, 2019
Actual Study Start Date January 1, 2017
Actual Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2019)
Best corrected visual acuity (BCVA) [ Time Frame: 2 years ]
Change in BCVA
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 31, 2019)
optical coherence tomography (OCT) foveal thickness [ Time Frame: 2 years ]
changes in central foveal thickness
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dexamethasone Intravitreal Implant (Ozurdex®) for Recurrent Vogt-Koyanagi-Harada (VKH) Disease Posterior Uveitis
Official Title Long Term Efficacy of Dexamethasone Intravitreal Implant (Ozurdex®) in Treatment of Recurrent VKH Uveitis
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 16 patient with VKH disease who have recurrent attacks of posterio uveitis
Condition Posterior Uveitis
Intervention Drug: Dexamethasone Ophthalmic implant
intravitreal injection of ozurdex implant
Other Name: ozurdex implant
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 31, 2019)
16
Original Estimated Enrollment Same as current
Actual Study Completion Date November 22, 2019
Actual Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Recurrent VKH posterior uveitis

Exclusion Criteria:

  • retinal pathology, other causes of posterior uveitis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number NCT03971279
Other Study ID Numbers hamaky2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
Study Sponsor Benha University
Collaborators Not Provided
Investigators
Principal Investigator: Tarek Elhamaky Benha university faculty of medicine , INMC
PRS Account Benha University
Verification Date November 2019