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NCT00476918 Clinical Trial

Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

Diabetic Retinopathy Clinical Trial

Official title:
Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00476918
Other study ID # 21091968
Secondary ID Insurance no.: 2
Status Recruiting
Phase Phase 1
First received May 21, 2007
Last updated May 21, 2007
Start date July 2006
Est. completion date December 2007

Study information
Verified date May 2007
Source Heidelberg University
Contact Ulrich HM Spandau, PhD MD
Phone +496213832242
Email ulrich.spandau@augen.ma.uni-heidelberg.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Intravitreal injection (triamcinolone acetonide)

Locations
Country Name City State
Germany Dep of Ophthalmology, University of Mannheim Mannheim

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity, no of treatments, duration of efficacy 12 months
Secondary intraocular pressure, retinal thickness 12 months
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