NCT00300014

Brief Summary

The Purpose of this study is compare the efficacy of intravitreal triamcinolone in clearing recurrent post-vitrectomy diabetic hemorrhage with conventional treatment, air-fluid exchange.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
unknown

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, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

June 13, 2007

Status Verified

June 1, 2007

First QC Date

March 7, 2006

Last Update Submit

June 12, 2007

Conditions

Post Vitrectomy StateRecurrent Diabetic Vitreous Hemorrhage

Keywords

Post vitrectomyRecurrent diabetic vitreous hemorrhageIntravitreal triamcinolone injection

Outcome Measures

Primary Outcomes (7)

  • day 1 : intraocular pressure, biomicroscope exam, fundus exam

  • day 7 : intraocular pressure, biomicroscope exam, fundus exam

  • 2 weeks : intraocular pressure, biomicroscope exam, fundus exam

  • 4weeks: intraocular pressure, biomicroscope exam, fundus exam, fluorescein angiography

  • 2 months : intraocular pressure, biomicroscope exam, fundus exam

  • 3months : intraocular pressure, biomicroscope exam, fundus exam

  • 6 months : intraocular pressure, biomicroscope exam, fundus exam

Interventions

Intravitreal triamcinolone injectionPROCEDURE
Air-fluid exchangePROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Previous vitrectomy due to proliferative diabetic retinopathy
  • Recurrent diabetic vitreous hemorrhage

You may not qualify if:

  • Monocular vision
  • Uncontrollable intraocular pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Study Officials

  • Sun Young Lee, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

  • He Won Chung, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

  • Young Hee Yoon, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

  • June-Gone Kim, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Young Lee, MD

CONTACT

82-2-3010-3970sunylee@amc.seoul.kr

June-Gone Kim, MD

CONTACT

82-2-3010-3673dropkim@dreamwiz.com

Study Design

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

Study Record Dates

First Submitted

March 7, 2006

First Posted

March 8, 2006

Study Start

January 1, 2006

Study Completion

May 1, 2007

Last Updated

June 13, 2007

Record last verified: 2007-06

Locations

KR(1)