NCT01053858

Brief Summary

To evaluate the effect of intravitreal bevacizumab with intravitreal triamcinolone for the treatment of central retinal vein occlusion (CRVO) presenting poor visual acuity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
Last Updated

January 22, 2010

Status Verified

January 1, 2010

Enrollment Period

1 year

First QC Date

January 14, 2010

Last Update Submit

January 20, 2010

Conditions

Central Retinal Vein Occlusion With 20/200 or Worse Visual Acuity

Keywords

bevacizumab,triamcinolone, intravitreal injection

Outcome Measures

Primary Outcomes (1)

  • best corrected visual acuity

    baseline, 1 month, 2 months, 3 months, 6 months, 12 months

Secondary Outcomes (1)

  • central macular thickness by optical coherence tomography

    baseline, 1 month, 2 months, 3 months, 6 months 12months

Study Arms (2)

bevacizumab

ACTIVE COMPARATOR

intravitreal bevacizumab or triamcinolone determined by single physician

Procedure: intravitreal injection

triamcinolone

ACTIVE COMPARATOR
Procedure: intravitreal injection

Interventions

intravitreal injectionPROCEDURE

intravitreal bevacizumab( 1.25 mg) or triamcinolone( 4mg) injection

bevacizumabtriamcinolone

Eligibility Criteria

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

You may qualify if:

  • central macular thickness of more than 250 μm and baseline visual acuity of 20/200 or worse than 20/200 in patient with central retinal vein occlusion

You may not qualify if:

  • previous treatment such as intravitreal injection, subtenon injection, or laser photocoagulation since the time of onset
  • Patients with a history of glaucoma, neovascular glaucoma, diabetic retinopathy, and macular disorders
  • neovascularization on the disc or elsewhere or rubeosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

keoung ik Na

Chuncheon, anyang, 135-060, South Korea

Location

MeSH Terms

Interventions

Intravitreal Injections

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeutics

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

January 14, 2010

First Posted

January 22, 2010

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2010

Last Updated

January 22, 2010

Record last verified: 2010-01

Locations

KR(1)