Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

Phase 1

• Conditions: Diabetic Retinopathy; Diabetic Macular Edema

• Registration Number: NCT00476918
• Lead Sponsor: Heidelberg University

Brief Summary

Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage versus a low dosage.

Detailed Description

Patients with diabetic retinopathy suffer from visual acuity loss caused by diabetic macular edema. Intravitreal injected Triamcinolone Acetonide (steroid) reduces macular edema and increases visual acuity. The duration of its effect is however limited. Therefore, several injections are necessary.

In this study a dosage dependency of triamcinolone acetonide (high dosage vs low dosage) is performed. The primary outcome parameters are the number of treatments and the efficacy of each injection.

Study Timeline

• Study Start: 2006-07
• Status Verified: 2007-05
• Study First Submitted: 2007-05-21
• Study First Submitted QC: 2007-05-21
• Last Update Submitted: 2007-05-21
• Study First Posted: 2007-05-22
• Last Update Posted: 2007-05-22
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• diabetic macular edema and visual acuity between 20/200 and 20/40 age over 18 years

Exclusion Criteria

• recent treatment with laser photocoagulation or intravitreal drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Visual acuity, no of treatments, duration of efficacy	12 months

Secondary Outcome Measures

Name	Time	Method
intraocular pressure, retinal thickness	12 months

Trial Locations

Locations (1)

Dep of Ophthalmology, University of Mannheim; 🇩🇪 Mannheim, Germany