NCT00478530

The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the scotopic and photopic ERG responses before and after one month of intravitreal avastin injection in patients with choroidal neovascularization. A positive finding that will reveal a toxic effect of intravitreal avastin injection on any component of the retina will have a significant important clinical impact regarding the decision whether the benefit of avastin treatment for CNV will prevail over toxic effect.

Detailed description

The study will include 20 patients who are diagnosed with CNV and were submitted for intravitreal injection of avastin. Patients with uncontrolled glaucoma, any ocular operation two months prior to the injection, ocular inflammatory disease, systemic hypertension treated with more than one medication, myocardial infarct, congestive heart disease will not be included in the study. After the patient will approve to participate in the study and will fall in with the inclusion and exclusion criteria, the patient will sign a written consent statement (enclosed). Medical history and ophthalmic examination will be written in the study file. The patients will undergo the full-field ERG test using the ISCEV Protocol. Since the ERG is a non invasive test the patient will be admitted on the same day for intravitreal avastin in the designated eye. After one month the patient will undergo identical ERG protocol in addition to the standard follow-up examinations protocol for intravitreal avastin injection (1 day, 1 week, 1 month). The other eye will serve as control group.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
PROCEDURE	ELECTRORETINOGRAM	Bevacizumab 1.25 mg/0.05 ml unilaterally into the vitreous cavity as part of the standard management for choroidal neovascular AMD. ERG responses form both eyes will be measured at baseline and 1 month after intravitreal injection

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-06-01
• Completion: 2008-10-01
• First posted: 2007-05-25
• Last updated: 2009-02-05

Locations

1 site across 1 country: Israel