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

Primary Purpose

Retinal Disease

Status

Completed

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Avastin (Bevacizumab)

About this trial

This is an interventional treatment trial for Retinal Disease focused on measuring intravitreal Avastin, BRVO, Macular edema

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Siamak Moradian, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm Description

Intravitreal injection of Avastin

Outcomes

Primary Outcome Measures

Best corrected visual acuity

Macular thickness by OCT

Secondary Outcome Measures

Need for macular photocuagulation

Incidence of new vessel formation

Full Information

NCT ID

NCT00370851

First Posted

August 31, 2006

Last Updated

November 23, 2009

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00370851

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Disease

Keywords

intravitreal Avastin, BRVO, Macular edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intravitreal injection of Avastin

Arm Title

Arm Type

Sham Comparator

Intervention Type

Drug

Intervention Name(s)

Avastin (Bevacizumab)

Intervention Description

Intravitreal injection of 125 mg Avastin

Primary Outcome Measure Information:

Title

Best corrected visual acuity

Time Frame

At 12 week

Title

Macular thickness by OCT

Time Frame

At 12 week

Secondary Outcome Measure Information:

Title

Need for macular photocuagulation

Time Frame

At 12th week

Title

Incidence of new vessel formation

Time Frame

At 12th week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Siamak Moradian, MD

Organizational Affiliation

Ophthalmic Research Center of Shaheed Beheshti Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siamak Moradian, MD

City

Tehran

ZIP/Postal Code

16666

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

21337043

Citation

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.

Results Reference

derived

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

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