Triamcinolone or Bevacizumab for Central Retinal Vein Occ... | NCT01053858

Studies
Triamcinolone or Bevacizumab for Central Retinal Vein Occlusion With Poor Vision

NCT01053858

Sponsor

Hallym University Medical Center

Status

Completed

Last Update Posted

Jan 22, 2010Estimated

Enrollment

38Actual

Phase

Not Applicable

Conditions

Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity

Interventions

intravitreal injection

Countries

South Korea

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2010Actual

First Submitted Date

Jan 14, 2010

First Submission Date that Met QC Criteria

Jan 20, 2010

First Posted Date

Jan 22, 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 20, 2010

Last Update Posted Date

Jan 22, 2010Estimated

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

To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bevacizumab	Active Comparator	intravitreal bevacizumab or triamcinolone determined by single physician	Procedure: intravitreal injection
triamcinolone	Active Comparator		Procedure: intravitreal injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intravitreal injection	Procedure	intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection	bevacizumab triamcinolone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
best corrected visual acuity		baseline, 1 month, 2 months, 3 months, 6 months, 12 months

Secondary Outcomes

Measure	Description	Time Frame
central macular thickness by optical coherence tomography		baseline, 1 month, 2 months, 3 months, 6 months 12months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

central macular thickness of more than 250 μm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion

Exclusion Criteria:

previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset
Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders
neovascularization on the disc or elsewhere or rubeosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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
keoung ik Na		Chuncheon	anyang	135-060	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D058449	Intravitreal Injections

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided