Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00300014
First received: March 7, 2006
Last updated: June 12, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention
Post Vitrectomy State
Recurrent Diabetic Vitreous Hemorrhage
Procedure: Intravitreal triamcinolone injection
Procedure: Air-fluid exchange

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative,Randomized Study Between Intravitreal Triamcinolone Acetonide and Air-Fluid Exchange in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: January 2006
Estimated Study Completion Date: May 2007
Detailed Description:

Vitreous hemorrhage is the most common complication of vitrectomy for diabetic retinopathy. Despite measures to prevent and control this bleeding, it can lead to air–fluid exchange in the office or to additional surgery in the operating room. Air-fluid exchange does not result in clear vision immediately after the procedure, and the patient has to maintain a face-down position. Vitreous lavage, a more invasive procedure performed in the operating room, may give rise to complications such as iatrogenic retinal breaks, incarcerations of vitreous in the sclerotomy sites, retinal detachment, rubeosis iridis, neovascular glaucoma, infective endophthalmitis, and sympathetic ophthalmia. In contrast, IVT injection as a treatment of post vitrectomy diabetic vitreous hemorrhage is a less invasive procedure and provides more prompt visual recovery, while avoiding the face-down position.

We believe that the rapid clearing of vitreous hemorrhage results from as follows: (1) triamcinolone delivered in vitreous cavity can give rise to mechanical sediment entangled with remaining blood (2) direct vascular stabilizing effect may be induced (3) antiangiogenic effect may play a role.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Monocular vision
  • Uncontrollable intraocular pressure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300014

Contacts
Contact: Sun Young Lee, MD 82-2-3010-3970 sunylee@amc.seoul.kr
Contact: June-Gone Kim, MD 82-2-3010-3673 dropkim@dreamwiz.com

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sun Young Lee, MD    82-2-3010-3970    sunylee@amc.seoul.kr   
Contact: June-Gone Kim, MD    82-3010-3673    dropkim@dreamwiz.com   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00300014     History of Changes
Other Study ID Numbers: IVT in vitreous hemorrhage
Study First Received: March 7, 2006
Last Updated: June 12, 2007
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:
Post vitrectomy
Recurrent diabetic vitreous hemorrhage
Intravitreal triamcinolone injection

Additional relevant MeSH terms:
Hemorrhage
Vitreous Hemorrhage
Pathologic Processes
Eye Hemorrhage
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014