Diabetic Retinopathy With Premacular Hemorrhage Clinical Trial
Official title:
Intravitreal Injection of Bevacizumab and Gas for Diabetic Premacular Hemorrhage With Active Fibrovascular Proliferation
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.
In this study, consecutive cases of acute diabetic premacular hemorrhage and active fibrovascular proliferation will receive intravitreal injection of bevacizumab (1.25 mg in 0.05 mL) and C3F8 (0.2-0.3 mL) during the same setting. Before intravitreal injection, all patients should either have complete panretinal photocoagulation (PRP) treatment or PRP to the peripheral retina. After treatment, patients will maintain a prone position for three days and be followed at regular interval. After vitreous clear-up, further supplementary PRP extending beyond equator will be done. Snellen best-corrected visual acuity measurements, intraocular pressure, slit-lamp examination and non-contact lens biomicroscopic examination will be performed before treatment and at each follow-up visit. Data including the extent of premacular hemorrhage, and the interval between the treatment and clearing of premacular hemorrhage will also be recorded. ;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment