Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

• ClinicalTrials.gov Identifier: NCT00476918
• Recruitment Status: Unknown
• First Posted: May 22, 2007
• Last Update Posted: May 22, 2007
• Sponsor: Heidelberg University
• Information provided by: Heidelberg University

Tracking Information

• First Submitted Date: May 21, 2007
• First Posted Date: May 22, 2007
• Last Update Posted Date: May 22, 2007
• Study Start Date: July 2006
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: May 21, 2007): Visual acuity, no of treatments, duration of efficacy [ Time Frame: 12 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: May 21, 2007): intraocular pressure, retinal thickness [ Time Frame: 12 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema
• Official Title: Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double; Primary Purpose: Treatment

Condition

• Diabetic Retinopathy
• Diabetic Macular Edema

• Intervention: Drug: Intravitreal injection (triamcinolone acetonide)
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 21, 2007): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2007
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00476918
• Other Study ID Numbers: 21091968; Insurance no.: 20-770-968594
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Heidelberg University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Jost Jonas, PhD MD; Dep of Ophthalmology, University of Mannheim

• PRS Account: Heidelberg University
• Verification Date: May 2007