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

Diabetic Retinopathy With Premacular Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00673296
• Other study ID #: 200711050R
• Status: Active, not recruiting
• Phase: N/A
• First received: May 5, 2008
• Last updated: May 5, 2008
• Start date: January 2007
• Est. completion date: December 2008

Study information

• Verified date: April 2008
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: December 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Diabetic Retinopathy With Premacular Hemorrhage
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

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. — View Citation

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. — View Citation

Lynch SS, Cheng CM. Bevacizumab for neovascular ocular diseases. Ann Pharmacother. 2007 Apr;41(4):614-25. Epub 2007 Mar 13. Review. — View Citation

Michels RG. Proliferative diabetic retinopathy: pathophysiology of extraretinal complications and principles of vitreous surgery. Retina. 1981;1(1):1-17. Review. — View Citation

Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8. — View Citation

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. — View Citation

Yang CM, Chen MS. Tissue plasminogen activator and gas for diabetic premacular hemorrhage. Am J Ophthalmol. 2000 Mar;129(3):393-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interval between the treatment and clearing of premacular hemorrhage		Before treatment, weekly after the treatment, and monthly after hemorrhage reabsorption	Yes
Secondary	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	Yes