Intravitreal Celecoxib for Chronic Uveitis

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02131012

Acronym

Celecoxib

Enrollment

Registered

2014-05-06

Start date

2015-06-30

Completion date

2016-11-01

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Keywords

Macular edema

Brief 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.

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.

Interventions

DRUGIntravitreal Celecoxib

1-4 mg intravitreal celecoxib

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 15 years or younger Have active ocular infection Pregnancy Phakic subjects

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Efficacy	12 weeks	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026