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Trial record 1 of 916 for:    triamcinolone acetonide
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Posterior Subtenon Versus Intravitreal Injection of Triamcinolone Acetonide for Treatment of Uveitic Cystoid Macular Edema

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ClinicalTrials.gov Identifier: NCT02598869
Recruitment Status : Withdrawn
First Posted : November 6, 2015
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Phoebe Lin, MD,PhD, Oregon Health and Science University

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)

Condition or disease Intervention/treatment Phase
Uveitis Cystoid Macular Edema Drug: Triamcinolone Acetonide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Posterior Subtenon Versus Intravitreal Injection of Triamcinolone Acetonide for Treatment of Uveitic Cystoid Macular Edema (CME)
Actual Study Start Date : November 30, 2015
Actual Primary Completion Date : May 15, 2016
Actual Study Completion Date : May 15, 2016


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:
  • triesence
  • kenalog

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:
  • triesence
  • kenalog




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Percentage of eyes that develop side effects [ Time Frame: at 1,3 and 6 months after intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications:
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Responsible Party: Phoebe Lin, MD,PhD, Assistant professor of Ophthalmology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02598869     History of Changes
Other Study ID Numbers: 00011584
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Keywords provided by Phoebe Lin, MD,PhD, Oregon Health and Science University:
Triamcinolone acetonide
Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Macular Edema
Uveitis
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action