Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478530
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2007-05-24
Brief Title:
The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None