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

• ClinicalTrials.gov Identifier: NCT03971279
• Recruitment Status: Completed
• First Posted: June 3, 2019
• Last Update Posted: November 26, 2019
• Sponsor: Benha University
• 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

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

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

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