NCT03971279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

2.9 years

First QC Date

May 30, 2019

Last Update Submit

November 24, 2019

Conditions

Posterior Uveitis

Keywords

dexamethasone;VKH

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity (BCVA)

    Change in BCVA

    2 years

Secondary Outcomes (1)

  • optical coherence tomography (OCT) foveal thickness

    2 years

Interventions

Dexamethasone Ophthalmic implantDRUG

intravitreal injection of ozurdex implant

Also known as: ozurdex implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Recurrent VKH posterior uveitis

You may not qualify if:

  • retinal pathology, other causes of posterior uveitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INMC

Abu Dhabi, United Arab Emirates

Location

MeSH Terms

Conditions

Uveitis, Posterior

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

PanuveitisUveitisUveal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Tarek Elhamaky

    Benha university faculty of medicine , INMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of ophthalmology

Study Record Dates

First Submitted

May 30, 2019

First Posted

June 3, 2019

Study Start

January 1, 2017

Primary Completion

November 22, 2019

Study Completion

November 22, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Locations

AE(1)