Clinical trial NCT00673296: Intravitreal Injection of Bevacizumab and Gas for Diabetic Premacular Hemorrhage With Active Fibrovascular Proliferation
Official title: Intravitreal Injection of Bevacizumab and Gas for Diabetic Premacular Hemorrhage With Active Fibrovascular Proliferation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Retinopathy With Premacular Hemorrhage
Keywords: Bevacizumab
Diabetic premacular hemorrhage
Intravitreal gas
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Acute diabetic premacular hemorrhage and minor active fibrovascular proliferation

Exclusion Criteria:

* Anticoagulant therapy
* Blood diseases associated with abnormal coagulation
* Proliferative retinopathy severe enough to warrant vitrectomy

Primary outcomes:
measure: Interval between the treatment and clearing of premacular hemorrhage
timeFrame: Before treatment, weekly after the treatment, and monthly after hemorrhage reabsorption
Secondary outcomes:
measure: Snellen best-corrected visual acuity measurements, intraocular pressure, slit-lamp examination and non-contact lens biomicroscopic examination.
timeFrame: Before treatment, weekly after the treatment, and monthly after hemorrhage reabsorption
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chung May Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Shih CW, Yang CM, Chen MS, Wang TJ. Intravitreal injection of bevacizumab and gas for diabetic premacular hemorrhage with active fibrovascular proliferation. Graefes Arch Clin Exp Ophthalmol. 2008 Nov;246(11):1547-51. doi: 10.1007/s00417-008-0902-8. Epub 2008 Aug 6.