Bevacizumab Versus Combined Bevacizumab and Triamcinolone... | NCT00370422

Studies
Bevacizumab Versus Combined Bevacizumab and Triamcinolone for Refractory Diabetic Macular Edema; a Randomized Clinical Trial

NCT00370422

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

Mar 13, 2007Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Diabetic Macular Edema

Interventions

Triamcinolone, Bevacizumab

Countries

Iran

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

Status Module

Record Verification Date

Oct 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Sep 2006

First Submitted Date

Aug 30, 2006

First Submission Date that Met QC Criteria

Aug 30, 2006

First Posted Date

Aug 31, 2006Estimated

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

Mar 12, 2007

Last Update Posted Date

Mar 13, 2007Estimated

Description Module

Brief Summary

The purpose of this study is to compare the efficacy and safety of intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory diabetic macular edema.

Detailed Description

According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema is laser therapy, which may be neither effective nor curative in some patients. Corticosteroids may have a beneficial effect on diabetic macular edema. Other newly introduced medications for macular edematous lesions are anti-VEGF vascular endothelial growth factor)drugs. In this randomized, sham-controlled, multicenter, three-arm clinical trial,we try to evaluate the safety and efficacy of intravitreal bevacizumab alone and in combination with intravitreal triamcinolone in the treatment of refractory diabetic macular edema.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Triamcinolone, Bevacizumab	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity
Central macular thickness

Secondary Outcomes

Measure	Description	Time Frame
Cataract progression
Intraocular pressure
Anterior chamber reaction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cases with clinically significant macular edema (CSME) with persistent retinal thickening after initial or supplemental macular photocoagulation

Exclusion Criteria:

Monocularity,
History of vitrectomy,
Glaucoma or ocular hypertension,
Significant media opacity,
Existence of traction on the macula

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hamid Ahmadieh, MD	Ophthalmic Research Center of Shaheed Beheshti Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamid Ahmadieh, MD		Tehran	Tehran Province	16666	Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17917738	Derived	Ahmadieh H, Ramezani A, Shoeibi N, Bijanzadeh B, Tabatabaei A, Azarmina M, Soheilian M, Keshavarzi G, Mohebbi MR. Intravitreal bevacizumab with or without triamcinolone for refractory diabetic macular edema; a placebo-controlled, randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2008 Apr;246(4):483-9. doi: 10.1007/s00417-007-0688-0. Epub 2007 Oct 5.

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds

ID	Term
D014221	Triamcinolone
D000068258	Bevacizumab