NCT02598869

Brief Summary

Macular edema is the most common sight threatening complication of uveitis which can lead to permanent loss of central vision. Triamcinolone acetonide ( the study drug)injection for treatment of cystoid macular edema(CME) is well established. The purpose of this study is to compare the safety and efficacy of injecting the study drug inside the eye(intravitreal injection) and behind the eye(subtenon injection)

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_4

Status
withdrawn

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

August 31, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

November 30, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2016

Completed
Last Updated

February 7, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

August 31, 2015

Last Update Submit

February 5, 2019

Conditions

UveitisCystoid Macular Edema

Keywords

Triamcinolone acetonide

Outcome Measures

Primary Outcomes (1)

  • Mean change in best corrected visual acuity( BCVA)

    Best corrected visual acuity will be assessed using the Snellen chart

    at 1,3 and 6 months after intervention

Secondary Outcomes (2)

  • Change in central macular thickness in micrometers

    at 1,3 and 6 months after intervention

  • Percentage of eyes that develop side effects

    at 1,3 and 6 months after intervention

Study Arms (2)

Intravitreal triamcinolone

ACTIVE COMPARATOR

subjects will receive intravitreal injection of 2mg /0.05 ml of preservative free triamcinolone acetonide ( otherwise known as triesence)

Drug: Triamcinolone Acetonide

posterior subtenon triamcinolone

ACTIVE COMPARATOR

subjects will receive posterior subtenon injection of 40mg /1 ml of preserved triamcinolone acetonide ( otherwise known as kenalog)

Drug: Triamcinolone Acetonide

Interventions

Triamcinolone AcetonideDRUG

injection of triamcinolone acetonide

Also known as: triesence, kenalog
Intravitreal triamcinoloneposterior subtenon triamcinolone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-pregnant female at least 18 years of age at the time of consent
  • One or both eyes having CME associated with non-infectious uveitis
  • Subject has the ability to understand and sign the Informed Consent Form
  • Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

You may not qualify if:

  • Allergy to triamcinolone acetonide
  • History of any type of non-infectious uveitis without macular edema
  • Vitreous hemorrhage
  • Uveitis with infectious etiology
  • CME due to non-uveitis causes
  • Previous viral retinitis or uveitis
  • Toxoplasmosis scar in study eye or scar related to viral retinitis
  • Media opacity interfering with optical coherence tomography (OCT) or evaluation of the retina and vitreous
  • Patient may not have had prior treatment for CME within the past 3 months including anti-VEGF (vascular endothelial growth factor), periocular or intravitreal steroid
  • Pregnant or nursing women; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
  • Subjects unwilling to comply with the study protocol or who are likely to be lost to follow-up within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Guex-Crosier Y. The pathogenesis and clinical presentation of macular edema in inflammatory diseases. Doc Ophthalmol. 1999;97(3-4):297-309. doi: 10.1023/a:1002130005227.

    PMID: 10896343BACKGROUND

  • Sivaprasad S, McCluskey P, Lightman S. Intravitreal steroids in the management of macular oedema. Acta Ophthalmol Scand. 2006 Dec;84(6):722-33. doi: 10.1111/j.1600-0420.2006.00698.x.

    PMID: 17083528BACKGROUND

  • Leder HA, Jabs DA, Galor A, Dunn JP, Thorne JE. Periocular triamcinolone acetonide injections for cystoid macular edema complicating noninfectious uveitis. Am J Ophthalmol. 2011 Sep;152(3):441-448.e2. doi: 10.1016/j.ajo.2011.02.009. Epub 2011 Jun 8.

    PMID: 21652023BACKGROUND

MeSH Terms

Conditions

UveitisMacular Edema

Interventions

Triamcinolone AcetonideTriamcinolone

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesMacular DegenerationRetinal DegenerationRetinal Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Ophthalmology

Study Record Dates

First Submitted

August 31, 2015

First Posted

November 6, 2015

Study Start

November 30, 2015

Primary Completion

May 15, 2016

Study Completion

May 15, 2016

Last Updated

February 7, 2019

Record last verified: 2019-02