Intravitreal Injection of Bevacizumab and Gas for Diabetic Premacular Hemorrhage With Active Fibrovascular Proliferation
|ClinicalTrials.gov Identifier: NCT00673296|
Recruitment Status : Unknown
Verified April 2008 by National Taiwan University Hospital.
Recruitment status was: Active, not recruiting
First Posted : May 7, 2008
Last Update Posted : May 7, 2008
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.
|Condition or disease||Intervention/treatment|
|Diabetic Retinopathy With Premacular Hemorrhage||Drug: Intravitreal Bevacizumab|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravitreal Injection of Bevacizumab and Gas for Diabetic Premacular Hemorrhage With Active Fibrovascular Proliferation|
|Study Start Date :||January 2007|
|Primary Completion Date :||April 2008|
|Estimated Study Completion Date :||December 2008|
Patients receive intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL)
Drug: Intravitreal Bevacizumab
Intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL)
- Interval between the treatment and clearing of premacular hemorrhage [ Time Frame: Before treatment, weekly after the treatment, and monthly after hemorrhage reabsorption ]
- Snellen best-corrected visual acuity measurements, intraocular pressure, slit-lamp examination and non-contact lens biomicroscopic examination. [ Time Frame: Before treatment, weekly after the treatment, and monthly after hemorrhage reabsorption ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673296
|National Taiwan University Hospital|
|Taipei, Taiwan, 10002|
|Principal Investigator:||Chung May Yang, M.D.||National Taiwan University Hospital|