Intravitreal Bevasizumab Versus Intravitreal Triamcinolon... | NCT01044329

Studies
Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Branch Retinal Vein Occlusion

NCT01044329

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

Jan 7, 2010Estimated

Enrollment

90Estimated

Phase

Phase 2

Conditions

Branch Retinal Vein Occlusion

Interventions

Bevacizumab
Triamcinolone Acetonide

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

Jan 2010

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

Jan 2010

Primary Completion Date

Aug 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jan 6, 2010

First Submission Date that Met QC Criteria

Jan 6, 2010

First Posted Date

Jan 7, 2010Estimated

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

Jan 6, 2010

Last Update Posted Date

Jan 7, 2010Estimated

Name	Class
Labbafinejad Medical Center	OTHER

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

This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravitreal bevacizumab	Active Comparator		Drug: Bevacizumab
Intravitreal triamcinolone	Active Comparator		Drug: Triamcinolone Acetonide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug	Intravitreal, 1.25 mg, 3 times, one month apart.	Intravitreal bevacizumab

Measure	Description	Time Frame
Visual acuity		6 months

Measure	Description	Time Frame
central macular thickness		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recent onset (less than 3 months) BRVO

Exclusion Criteria:

Any previous intervention

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imam Hossein medical center	Recruiting	Tehran			Iran

Condition Browse Module

MeSH Terms

ID	Term
D012170	Retinal Vein Occlusion

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D020246	Venous Thrombosis
D013927	Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab
D014222	Triamcinolone Acetonide

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided