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Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

Information source: Heidelberg University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Retinopathy; Diabetic Macular Edema

Intervention: Intravitreal injection (triamcinolone acetonide) (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Heidelberg University

Official(s) and/or principal investigator(s):
Jost Jonas, PhD MD, Study Director, Affiliation: Dep of Ophthalmology, University of Mannheim

Overall contact:
Ulrich HM Spandau, PhD MD, Phone: +496213832242, Email: ulrich.spandau@augen.ma.uni-heidelberg.de

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.

Clinical Details

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

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

Primary outcome: Visual acuity, no of treatments, duration of efficacy

Secondary outcome: intraocular pressure, retinal thickness

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ulrich HM Spandau, PhD MD, Phone: +496213832242, Email: ulrich.spandau@augen.ma.uni-heidelberg.de

Dep of Ophthalmology, University of Mannheim, Mannheim 68167, Germany; Recruiting
Ulrich HM Spandau, PhD MD, Principal Investigator
Additional Information

Starting date: July 2006
Last updated: May 21, 2007

Page last updated: August 23, 2015

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