Posterior Subtenon Versus Intravitreal Injection of Triamcinolone Acetonide for Treatment of Uveitic Cystoid Macular Edema

February 5, 2019 updated by: Phoebe Lin, MD,PhD, Oregon Health and Science University

Posterior Subtenon Versus Intravitreal Injection of Triamcinolone Acetonide for Treatment of Uveitic Cystoid Macular Edema (CME)

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)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The study is randomized interventional non inferiority study that will enroll 30 adults aged 18 or older with the diagnosis of cystoid macular edema secondary to non-infectious uveitis. Potential subjects will be recruited from the retina and uveitis clinics at the Casey Eye Institute, Oregon health and science University(OHSU). Potential recruits will be asked to sign and date the informed consent and a copy will be given to subject prior to any study procedure. Subjects will have a screening visit before the injection procedure so that the study doctor can decide if they meet the criteria to be in the study. This study requires 6 visits to the clinic and will take 6 months to complete. During the screening visit, medical/ surgical/ ocular history and will be collected from the subject and medical records. Laboratory tests will be performed to rule out infectious uveitis if the subject has not already had infectious types of uveitis ruled out since the time of diagnosis of uveitis. Urine collection for pregnancy test for females of childbearing potential will be done. Examination of subjects will include measurement of visual acuity, examination of the front and back part of the eye, measurement of the eye pressure . A scan of the retina will be obtained by spectral domain optical coherence tomography (SD-OCT). During the injection visit, history, examination, and pregnancy tests will be repeated in addition to receiving the injection. Subjects will be randomized to either injecting the study drug by intravitreal or subtenon routes. Examination after injection will be performed to rule out immediate complications. Then subjects will have 4 follow-up visits (2 weeks, 1 month, 3 months and 6 months). During each visit, subjects will be asked about adverse events, concomitant medications, how their eyes feel in addition to obtaining a clinical examination and OCT.

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intravitreal triamcinolone
subjects will receive intravitreal injection of 2mg /0.05 ml of preservative free triamcinolone acetonide ( otherwise known as triesence)
Drug: Triamcinolone Acetonide
injection of triamcinolone acetonide
Other Names:
  • kenalog
  • triesence
ACTIVE_COMPARATOR: posterior subtenon triamcinolone
subjects will receive posterior subtenon injection of 40mg /1 ml of preserved triamcinolone acetonide ( otherwise known as kenalog)
Drug: Triamcinolone Acetonide
injection of triamcinolone acetonide
Other Names:
  • kenalog
  • triesence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in best corrected visual acuity( BCVA)
Time Frame: at 1,3 and 6 months after intervention
Best corrected visual acuity will be assessed using the Snellen chart
at 1,3 and 6 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in central macular thickness in micrometers
Time Frame: at 1,3 and 6 months after intervention
A spectral domain optical coherence tomography device will be used to capture central macular thickness
at 1,3 and 6 months after intervention
Percentage of eyes that develop side effects
Time Frame: at 1,3 and 6 months after intervention
at 1,3 and 6 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 30, 2015

Primary Completion (ACTUAL)

May 15, 2016

Study Completion (ACTUAL)

May 15, 2016

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (ESTIMATE)

November 6, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2019

Last Update Submitted That Met QC Criteria

February 5, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00011584

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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