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

Post Vitrectomy State Clinical Trial

Official title:

Comparative,Randomized Study Between Intravitreal Triamcinolone Acetonide and Air-Fluid Exchange in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00300014
• Other study ID #: IVT in vitreous hemorrhage
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2006
• Last updated: June 12, 2007
• Start date: January 2006
• Est. completion date: May 2007

Study information

• Verified date: June 2007
• Source: Asan Medical Center
• Contact: Sun Young Lee, MD
• Phone: 82-2-3010-3970
• Email: sunylee[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Previous vitrectomy due to proliferative diabetic retinopathy

• Recurrent diabetic vitreous hemorrhage

Exclusion Criteria:

• Monocular vision

• Uncontrollable intraocular pressure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Post Vitrectomy State
• Recurrent Diabetic Vitreous Hemorrhage
• Vitreous Hemorrhage

Intervention

Procedure:
• Intravitreal triamcinolone injection

• Air-fluid exchange

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	day 1 : intraocular pressure, biomicroscope exam, fundus exam
Primary	day 7 : intraocular pressure, biomicroscope exam, fundus exam
Primary	2 weeks : intraocular pressure, biomicroscope exam, fundus exam
Primary	4weeks: intraocular pressure, biomicroscope exam, fundus exam, fluorescein angiography
Primary	2 months : intraocular pressure, biomicroscope exam, fundus exam
Primary	3months : intraocular pressure, biomicroscope exam, fundus exam
Primary	6 months : intraocular pressure, biomicroscope exam, fundus exam