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Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

Primary Purpose

Diabetic Retinopathy, Diabetic Macular Edema

Status

Unknown status

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Intravitreal injection (triamcinolone acetonide)

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring diabetic macular edema, triamcinolone acetonide, intravitreal, steroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dep of Ophthalmology, University of MannheimRecruiting

Outcomes

Primary Outcome Measures

Visual acuity, no of treatments, duration of efficacy

Secondary Outcome Measures

intraocular pressure, retinal thickness

Full Information

NCT ID

NCT00476918

First Posted

May 21, 2007

Last Updated

May 21, 2007

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT00476918

Brief Title

Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

Official Title

Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Unknown status

Study Start Date

July 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy, Diabetic Macular Edema

Keywords

diabetic macular edema, triamcinolone acetonide, intravitreal, steroid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Intravitreal injection (triamcinolone acetonide)

Primary Outcome Measure Information:

Title

Visual acuity, no of treatments, duration of efficacy

Time Frame

12 months

Secondary Outcome Measure Information:

Title

intraocular pressure, retinal thickness

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ulrich HM Spandau, PhD MD

Phone

+496213832242

ulrich.spandau@augen.ma.uni-heidelberg.de

First Name & Middle Initial & Last Name or Official Title & Degree

Anne Wickenhaeuser, MD

Phone

+496213832242

anne.wickenhäuser@augen.ma.uni-heidelberg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jost Jonas, PhD MD

Organizational Affiliation

Dep of Ophthalmology, University of Mannheim

Official's Role

Study Director

Facility Information:

Facility Name

Dep of Ophthalmology, University of Mannheim

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ulrich HM Spandau, PhD MD

12. IPD Sharing Statement

Learn more about this trial

Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

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