Dexamethasone Intravitreal Implant (Ozurdex®) for Recurre... | NCT03971279

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

NCT03971279

Sponsor

Benha University

Status

Completed

Last Update Posted

Nov 26, 2019Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Posterior Uveitis

Interventions

Dexamethasone Ophthalmic implant

Countries

United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Nov 22, 2019Actual

Completion Date

Nov 22, 2019Actual

First Submitted Date

May 30, 2019

First Submission Date that Met QC Criteria

May 31, 2019

First Posted Date

Jun 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2019

Last Update Posted Date

Nov 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tarek Roshdy mohamed Mahgoub ELhamaky, Lecturer of ophthalmology, Benha UniversityPrincipal Investigator

Lead Sponsor

Benha UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone Ophthalmic implant	Drug	intravitreal injection of ozurdex implant		ozurdex implant

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recurrent VKH posterior uveitis

Exclusion Criteria:

retinal pathology, other causes of posterior uveitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tarek Elhamaky	Benha university faculty of medicine , INMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INMC		Abu Dhabi			United Arab Emirates

Condition Browse Module

MeSH Terms

ID	Term
D015866	Uveitis, Posterior

Ancestor Terms

ID	Term
D015864	Panuveitis
D014605	Uveitis
D014603	Uveal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002123	Calcium Dobesilate

Ancestor Terms

ID	Term
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided