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

• Status: Withdrawn
• Trial end date: 2016-05-15
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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