NCT01219205

Brief Summary

Although it is important in the clinical management to classify BRVO into subtypes based on the location of the occlusion (major or macular), few studies have provided such information\[8,9\]. The aim of this study was to evaluate the outcome of patients with macular edema due to Branch retinal vein occlusion who were treated with intravitreal bevacizumab injection and to determine the concentrations of cytokines in the aqueous humor according to the site of the occlusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

Enrollment Period

11 months

First QC Date

October 10, 2010

Last Update Submit

October 12, 2010

Conditions

Keywords

macular edema secondary to retinal benous occlusion

Outcome Measures

Primary Outcomes (1)

  • efficacy of intravitreal bevacizumab

    the number on intravitreal bevacizumab during follow-up

    baseline and 12 months after initial injection

Secondary Outcomes (1)

  • cytokine levels in aqueous humor

    before intravitreal injection

Study Arms (2)

major branched retinal venous occlusion

ACTIVE COMPARATOR
Procedure: intravitreal bevacizumab

macular branched retinal venous occlusion

ACTIVE COMPARATOR
Procedure: intravitreal bevacizumab

Interventions

Intravitreal injections of bevacizumab were performed under sterile conditions in the operating room. a 27-gauge needle was inserted through the corneal limbus to withdraw 0.05 ml of aqueous humor and soften the globe. Then, 1.25 mg (0.05 ㎖) of bevacizumab was injected into the vitreous in the superior temporal quadrant with a 30-gauge needle that was inserted into the eye 3.5 mm from the limbus. The postoperative medications included topical antibiotics.

macular branched retinal venous occlusionmajor branched retinal venous occlusion

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • macular edema involving the center of the fovea with a minimum central macular thickness at baseline of ≥250 μm

You may not qualify if:

  • previous vitreoretinal surgery, intravitreal injections or laser treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji Won Lim

Chuncheon, Gangwon-do, 200-704, South Korea

Location

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Ji Won Lim, Prof

    Hallym Medical center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 10, 2010

First Posted

October 13, 2010

Study Start

March 1, 2008

Primary Completion

February 1, 2009

Study Completion

August 1, 2010

Last Updated

October 13, 2010

Record last verified: 2010-10

Locations