Intravitreal Triamcinolone Acetonide for Diabetic Macular... | NCT00476918

Studies
Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

NCT00476918

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

May 22, 2007Estimated

Enrollment

60Estimated

Phase

Phase 1

Conditions

Diabetic Retinopathy
Diabetic Macular Edema

Interventions

Intravitreal injection (triamcinolone acetonide)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Insurance no.: 20-770-968594

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

Dec 2007Estimated

First Submitted Date

May 21, 2007

First Submission Date that Met QC Criteria

May 21, 2007

First Posted Date

May 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2007

Last Update Posted Date

May 22, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
Intravitreal injection (triamcinolone acetonide)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity, no of treatments, duration of efficacy		12 months

Secondary Outcomes

Measure	Description	Time Frame
intraocular pressure, retinal thickness		12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ulrich HM Spandau, PhD MD	Contact	+496213832242		ulrich.spandau@augen.ma.uni-heidelberg.de
Anne Wickenhaeuser, MD	Contact	+496213832242		anne.wickenhäuser@augen.ma.uni-heidelberg.de

Overall Officials

Name	Affiliation	Role
Jost Jonas, PhD MD	Dep of Ophthalmology, University of Mannheim	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dep of Ophthalmology, University of Mannheim	Recruiting	Mannheim		68167	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058449	Intravitreal Injections
D014222	Triamcinolone Acetonide

Ancestor Terms

ID	Term
D056965	Injections, Intraocular
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy

Browse Leaves

Not provided

Browse Branches

Not provided