The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram
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|ClinicalTrials.gov Identifier: NCT00478530|
Recruitment Status : Completed
First Posted : May 25, 2007
Last Update Posted : February 5, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Macular Degeneration||Procedure: ELECTRORETINOGRAM||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||October 2008|
- 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
- electroretinogram responses [ Time Frame: before treatment and one month after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478530
|Sheba Medical Center|
|Ramat Gan, Israel, 52621|
|Principal Investigator:||YGAL ROTENSTREICH||Sheba Medical Center|