NCT00370851

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

1.5 years

First QC Date

August 31, 2006

Last Update Submit

November 23, 2009

Conditions

Retinal Disease

Keywords

intravitreal AvastinBRVOMacular edema

Outcome Measures

Primary Outcomes (2)

  • Best corrected visual acuity

    At 12 week

  • Macular thickness by OCT

    At 12 week

Secondary Outcomes (2)

  • Need for macular photocuagulation

    At 12th week

  • Incidence of new vessel formation

    At 12th week

Study Arms (2)

1

EXPERIMENTAL

Intravitreal injection of Avastin

Drug: Avastin (Bevacizumab)

2

SHAM COMPARATOR
Drug: Avastin (Bevacizumab)

Interventions

Avastin (Bevacizumab)DRUG

Intravitreal injection of 125 mg Avastin

12

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with acute BRVO with less than three month duration

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siamak Moradian, MD

Tehran, Tehran Province, 16666, Iran

Location

Related Publications (1)

  • 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.

    PMID: 21337043DERIVED

MeSH Terms

Conditions

Retinal DiseasesMacular Edema

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Eye DiseasesMacular DegenerationRetinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Siamak Moradian, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 1, 2006

Study Start

August 1, 2006

Primary Completion

February 1, 2008

Study Completion

June 1, 2008

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

IR(1)