InflammationPhase 1CelecoxibNCT02131012

Intravitreal Celecoxib for Chronic Uveitis

A Phase 1 study testing Intravitreal Celecoxib in people with Inflammation, run by Vanderbilt University.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Intraocular delivery of celecoxib will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects. Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Inflammation
What is being tested?: Intravitreal Celecoxib
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: No sites listed yet
Study dates: Jun 2015to 1 Nov 2016
Phase: Phase 1
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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Chronic inflammation and/or macular edema despite maximal medical treatment Unable to tolerate corticosteroids due to side effects Aphakic or Pseudophakic subjects

Who cannot join

15 years or younger Have active ocular infection Pregnancy Phakic subjects

About this study

Official title: Intravitreal Celecoxib for Chronic Uveitis: A Phase I Investigational Safety Study

Read the detailed description

Specific Aims I: Test the safety of intraocular injection of 1mg and 4mg celecoxib in patients who have chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects.

II: Test the efficacy of intraocular 1mg and 4mg celecoxib in treating inflammation or structural complications of inflammation (macular edema) in patients who are unable to tolerate corticosteroids due to their side effects.

After investigational new drug application and Vanderbilt Institutional Review Board approval, celecoxib will be compounded by the Investigational Drug Service of the Vanderbilt Medical Center and packaged in individual sterile single use syringes for intraocular injection within 2 hours of preparation. Pharmaceutical grade celecoxib will be obtained from the drug manufacturer (Pfizer) with certificate analysis and compounded in sterile dimethyl sulfoxide following strict sterile technique.

Conditions: Inflammation
Being tested: Intravitreal Celecoxib
Keywords: Macular edema
Medical subject headings: Inflammation, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravitreal CelecoxibDrug
Also called Celebrex, NSAIDS
1-4 mg intravitreal celecoxib

Study groups in NCT02131012
Study group	Role	What they receive
Celecoxib	Experimental	1-4 mg intravitreal injection ofCelecoxib Receives: Drug: Intravitreal Celecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety
Participant will receive an intravitreal injection of the Celecoxib and be followed for any possible adverse events
Measured: 12 weeks

Secondary outcomes (1)

Efficacy
Participant will receive the intravitreal injection of celecoxib day 1 and be followed for efficacy. The efficacy will be determined from the ophthalmic exams and aqueous samples
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 20151 Nov 2016

First posted6 May 2014 (estimated)
Study startJun 2015
Primary completion1 Nov 2016
Study completion1 Nov 2016

Why it stopped: Difficulty recruiting

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InflammationStudies of the same condition, open and under way.
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: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02131012
Sponsor's protocol ID: IND for Celecoxib
Acronym: Celecoxib
Status last verified: Feb 2017
First submitted: 1 May 2014
Last updated: 23 Feb 2017
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Inflammation trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravitreal Celecoxib for Chronic Uveitis: A Phase I Investigational Safety Study
ClinicalTrials.gov ID: NCT02131012
Acronym / sponsor ID: Celecoxib / IND for Celecoxib
Conditions: Inflammation
Keywords: Macular edema
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty recruiting
Enrolment: 4 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Collaborators: Pfizer
Study start: Jun 2015 (actual)
Primary completion: 1 Nov 2016 (actual)
Study completion: 1 Nov 2016 (actual)
First posted: 6 May 2014 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Celecoxib	Experimental	Drug: Intravitreal Celecoxib1-4 mg intravitreal injection ofCelecoxib

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Chronic inflammation and/or macular edema despite maximal medical treatment Unable to tolerate corticosteroids due to side effects Aphakic or Pseudophakic subjects

Key exclusion criteria (1 listed)

15 years or younger Have active ocular infection Pregnancy Phakic subjects

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
Intravitreal CelecoxibAlso: Celebrex, NSAIDS1-4 mg intravitreal celecoxib	Drug	Celecoxib

Primary outcome

Safety
Time frame: 12 weeks
Participant will receive an intravitreal injection of the Celecoxib and be followed for any possible adverse events

1 secondary outcome

Efficacy
Time frame: 12 weeks

Results and safety

The study was stopped early (reason given: Difficulty recruiting). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.

Related trials for Inflammation

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TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Not yet recruiting
Investigation of the Gut-Brain Axis in Alcohol Use Disorder
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RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
RecruitingObservational study
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Enrolling by invitationObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intravitreal Celecoxib in people with Inflammation, run by Vanderbilt University.

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: stopped early, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Difficulty recruiting). Results are not available in the source record.

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?

Safety (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02131012.

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 23 Feb 2017.