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Intravitreal Injection of Bevacizumab and Gas for Diabetic Premacular Hemorrhage With Active Fibrovascular Proliferation

NCT00673296 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2008-05-07

No results posted yet for this study

Summary

Diabetic premacular hemorrhage occurs when blood from preretinal neovascular tissue is entrapped between the retina and the posterior hyaloid in the macular area. It may occur spontaneously or secondary to traction from a localized posterior vitreous detachment. This complication may greatly disturb the central vision and may be an important stimulant of fibrovascular proliferation.

Bevacizumab (Avastin, Genentech, Inc.) is a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), which has been used to treat a variety of neovascular ocular diseases. In proliferative diabetic retinopathy, intravitreal bevacizumab has been shown to induce prompt regression of neovascularization and may enhance resolution of vitreous hemorrhage.

In this study, we propose that simultaneous intravitreal injection of gas and bevacizumab may be a useful treatment option in diabetic premacular hemorrhage with active fibrovascular tissue. In this procedure, gas is used to displace the blood while bevacizumab may render the neovascularization less active to decrease the likelihood of recurrent hemorrhage.

Conditions

  • Diabetic Retinopathy With Premacular Hemorrhage

Interventions

DRUG

Intravitreal Bevacizumab

Intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL)

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Chung May Yang, M.D. · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-04-30
Completion
2008-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00673296 on ClinicalTrials.gov