Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema
Information source: University of Heidelberg
Information obtained from ClinicalTrials.gov on October 19, 2009
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: University of Heidelberg 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: Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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
Ending date: December 2007
Last updated: May 21, 2007
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