Intravitreal Injection of Bevacizumab and Gas for Diabetic Premacular Hemorrhage With Active Fibrovascular Proliferation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: A 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)
|
Outcome Measures
Primary Outcome Measures
- Interval between the treatment and clearing of premacular hemorrhage [Before treatment, weekly after the treatment, and monthly after hemorrhage reabsorption]
Secondary Outcome Measures
- Snellen best-corrected visual acuity measurements, intraocular pressure, slit-lamp examination and non-contact lens biomicroscopic examination. [Before treatment, weekly after the treatment, and monthly after hemorrhage reabsorption]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital | Taipei | Taiwan | 10002 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Chung May Yang, M.D., National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Arevalo JF, Maia M, Flynn HW Jr, Saravia M, Avery RL, Wu L, Eid Farah M, Pieramici DJ, Berrocal MH, Sanchez JG. Tractional retinal detachment following intravitreal bevacizumab (Avastin) in patients with severe proliferative diabetic retinopathy. Br J Ophthalmol. 2008 Feb;92(2):213-6. Epub 2007 Oct 26.
- Chung J, Kim MH, Chung SM, Chang KY. The effect of tissue plasminogen activator on premacular hemorrhage. Ophthalmic Surg Lasers. 2001 Jan-Feb;32(1):7-12.
- Lynch SS, Cheng CM. Bevacizumab for neovascular ocular diseases. Ann Pharmacother. 2007 Apr;41(4):614-25. Epub 2007 Mar 13. Review.
- Michels RG. Proliferative diabetic retinopathy: pathophysiology of extraretinal complications and principles of vitreous surgery. Retina. 1981;1(1):1-17. Review.
- Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8.
- Verheul HM, Jorna AS, Hoekman K, Broxterman HJ, Gebbink MF, Pinedo HM. Vascular endothelial growth factor-stimulated endothelial cells promote adhesion and activation of platelets. Blood. 2000 Dec 15;96(13):4216-21.
- Yang CM, Chen MS. Tissue plasminogen activator and gas for diabetic premacular hemorrhage. Am J Ophthalmol. 2000 Mar;129(3):393-4.
- 200711050R