The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram|
- electroretinogram responses [ Time Frame: before treatment and one month after treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||October 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478530
|Sheba Medical Center|
|Ramat Gan, Israel, 52621|
|Principal Investigator:||YGAL ROTENSTREICH||Sheba Medical Center|