Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO:... | NCT00370851

Studies
Intravitreal Bevasizumab VS Sham Treatment in Acute BRVO: A Randomized Clinical Trial

NCT00370851

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Nov 25, 2009Estimated

Enrollment

82Actual

Phase

Phase 3

Conditions

Retinal Disease

Interventions

Avastin (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

Nov 2009

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

Aug 2006

Primary Completion Date

Feb 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Aug 31, 2006

First Submission Date that Met QC Criteria

Aug 31, 2006

First Posted Date

Sep 1, 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

Nov 23, 2009

Last Update Posted Date

Nov 25, 2009Estimated

Description Module

Brief Summary

In this study we intend to evaluate the outcome of intravitreal avastin on improving the visual acuity and macular edema and late complications of BRVO like NVD and NVE

Detailed Description

After diabetic retinopathy, vein occlusion is the second most common retinovascular disease. According to BVO study the only effective management of it is macular photocoagulation for macular thickening that persist after 3 months.But we may miss a golden time which resulted to photoreceptor degeneration due to macular edema during this period. VEGF inhibitors newly have been shown that may be effective on a wide range of retinovascular diseases that resulted to macular edema or new vessels formation. In this study we aim to show the outcomes of one of this VEGF inhibitors (bevacizumab) on complications of BRVO in a sham controlled clinical trial.

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

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Intravitreal injection of Avastin	Drug: Avastin (Bevacizumab)
2	Sham Comparator		Drug: Avastin (Bevacizumab)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Avastin (Bevacizumab)	Drug	Intravitreal injection of 125 mg Avastin	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best corrected visual acuity		At 12 week
Macular thickness by OCT		At 12 week

Secondary Outcomes

Measure	Description	Time Frame
Need for macular photocuagulation		At 12th week
Incidence of new vessel formation		At 12th week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with acute BRVO with less than three month duration

Exclusion Criteria:

vision less than 20/320 and vison more than 20/50
duration more than 3 months
history of glaucoma and diabetic retinopathy
any media opacity that prevent funduscopy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 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

Name	Affiliation	Role
Siamak Moradian, MD	Ophthalmic Research Center of Shaheed Beheshti Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Siamak Moradian, MD		Tehran	Tehran Province	16666	Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21337043	Derived	Moradian S, Faghihi H, Sadeghi B, Piri N, Ahmadieh H, Soheilian M, Dehghan MH, Azarmina M, Esfahani MR. Intravitreal bevacizumab vs. sham treatment in acute branch retinal vein occlusion with macular edema: results at 3 months (Report 1). Graefes Arch Clin Exp Ophthalmol. 2011 Feb;249(2):193-200. doi: 10.1007/s00417-010-1440-8. Epub 2010 Aug 18.

ID	Term
D012164	Retinal Diseases
D008269	Macular Edema

ID	Term
D005128	Eye Diseases
D008268	Macular Degeneration
D012162	Retinal Degeneration

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