Bevacizumab for Central Retinal Vein Occlusion Study | NCT00906685

Studies
Bevacizumab for Central Retinal Vein Occlusion Study

NCT00906685

Sponsor

Anders Kvanta

Status

Completed

Last Update Posted

Nov 22, 2011Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Central Retinal Vein Occlusion

Interventions

bevacizumab
Sham bevacizumab injection

Countries

Sweden

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

Nov 2011

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

May 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

May 20, 2009

First Submission Date that Met QC Criteria

May 20, 2009

First Posted Date

May 21, 2009Estimated

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

Nov 21, 2011

Last Update Posted Date

Nov 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravitreal bevacizumab	Active Comparator		Drug: bevacizumab
Sham injection	Sham Comparator		Drug: Sham bevacizumab injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab	Drug	Intravitreal injection of 1.25 mg bevacizumab	Intravitreal bevacizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of patients gaining 15 ETDRS letters or more		6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in foveal thickness		6 months
Cases of neovascular glaucoma		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CRVO with duration < 6 months
Visual acuity of 20/800 to 20/50

Exclusion Criteria:

CRVO with duration of > 6 months
previous treatment with anti-angiogenic drugs

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
Anders Kvanta, MD, PhD	St Eriks Eye Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Eriks Eye Hospital		Stockholm		11282	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D012170	Retinal Vein Occlusion
D008269	Macular Edema

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

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided