NCT02131012

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2015

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

May 1, 2014

Last Update Submit

February 20, 2017

Conditions

Inflammation

Keywords

Macular edema

Outcome Measures

Primary Outcomes (1)

  • Safety

    Participant will receive an intravitreal injection of the Celecoxib and be followed for any possible adverse events

    12 weeks

Secondary Outcomes (1)

  • Efficacy

    12 weeks

Study Arms (1)

Celecoxib

EXPERIMENTAL

1-4 mg intravitreal injection ofCelecoxib

Drug: Intravitreal Celecoxib

Interventions

Intravitreal CelecoxibDRUG

1-4 mg intravitreal celecoxib

Also known as: Celebrex, NSAIDS
Celecoxib

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • years or younger Have active ocular infection Pregnancy Phakic subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InflammationMacular Edema

Interventions

CelecoxibAnti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMacular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 6, 2014

Study Start

June 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02