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Sponsored by: |
Sheba Medical Center |
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Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00478530 |
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 | Intervention |
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Macular Degeneration |
Procedure: ELECTRORETINOGRAM |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram |
Estimated Enrollment: | 20 |
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.
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sheba Medical Center ( Ygal Rotenstreich ) |
Study ID Numbers: | SHEBA-07-4573-YR-CTIL |
Study First Received: | May 24, 2007 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00478530 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Eye Diseases Retinal Degeneration Macular Degeneration Bevacizumab Retinal Diseases |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |