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

NCT ID: NCT02598869

Last Updated: 2019-02-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-05-15

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)

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.

Conditions

Uveitis; Cystoid Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intravitreal triamcinolone

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

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type: DRUG

injection of triamcinolone acetonide

posterior subtenon triamcinolone

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

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type: DRUG

injection of triamcinolone acetonide

Interventions

Triamcinolone Acetonide

injection of triamcinolone acetonide

Intervention Type: DRUG

Other Intervention Names

triesence; kenalog

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Phoebe Lin, MD,PhD

Assistant professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 10896343 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17083528 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21652023 (View on PubMed)

Other Identifiers

00011584

Identifier Type: -

Identifier Source: org_study_id