Posterior UveitisNCT03971279
Dexamethasone Intravitreal Implant (Ozurdex®) for Recurrent Vogt-Koyanagi-Harada (VKH) Disease Posterior Uveitis
An observational study of Posterior Uveitis, run by Benha University at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Uveitis
- What is being tested?
- Dexamethasone Ophthalmic implant
- Type of treatment
- Injection or infusion
- How many people
- 16 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jan 2017to 22 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 16 patient with VKH disease who have recurrent attacks of posterio uveitis
Who may be able to join
- Recurrent VKH posterior uveitis
Who cannot join
- retinal pathology, other causes of posterior uveitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Efficacy of Dexamethasone Intravitreal Implant (Ozurdex®) in Treatment of Recurrent VKH Uveitis
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.
Read the 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)
- Conditions
- Posterior Uveitis
- Being tested
- Dexamethasone Ophthalmic implant
- Keywords
- dexamethasone;VKH
- Medical subject headings
- Uveitis, Posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Ophthalmic implantDrug
Also called ozurdex implant
intravitreal injection of ozurdex implant
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA)
Change in BCVA
Measured: 2 years
Secondary outcomes (1)
optical coherence tomography (OCT) foveal thickness
changes in central foveal thickness
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Jan 2017
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior UveitisStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
- Investigators
- Tarek Elhamaky, Principal investigator, Benha university faculty of medicine , INMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971279
- Sponsor's protocol ID
- hamaky2
- Status last verified
- Nov 2019
- First submitted
- 30 May 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Efficacy of Dexamethasone Intravitreal Implant (Ozurdex®) in Treatment of Recurrent VKH Uveitis
- ClinicalTrials.gov ID
- NCT03971279
- Acronym / sponsor ID
- hamaky2
- Conditions
- Posterior Uveitis
- Keywords
- dexamethasone;VKH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 16 patient with VKH disease who have recurrent attacks of posterio uveitis
Key inclusion criteria (1 listed)
- Recurrent VKH posterior uveitis
Key exclusion criteria (1 listed)
- retinal pathology, other causes of posterior uveitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone Ophthalmic implantAlso: ozurdex implantintravitreal injection of ozurdex implant | Drug | – |
Primary outcome
Best corrected visual acuity (BCVA)
Time frame: 2 years
Change in BCVA
1 secondary outcome
optical coherence tomography (OCT) foveal thickness
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Elhamaky principal investigator
Benha university faculty of medicine , INMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Uveitis, run by Benha University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (BCVA) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.