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The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

This study has been completed.
Information provided by:
Sheba Medical Center Identifier:
First received: May 24, 2007
Last updated: February 4, 2009
Last verified: February 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 Intervention
Macular Degeneration Procedure: ELECTRORETINOGRAM

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • electroretinogram responses [ Time Frame: before treatment and one month after treatment ]

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)
Intervention Details:
    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
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.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients who were diagnosed with CNV caused by ARMD
  2. ERG can be performed in both eyes

Exclusion Criteria:

  1. Treatment within 7 days with VERTOPROFIN
  2. Treatment within one month with laser photocoagulation
  3. Ocular surgery for AMD (besides laser).
  4. Participation in other medical study
  5. Sub-fovea RPE atrophy in the study eye.
  6. CNV with ocular histoplasmosis, trauma, pathological myopia.
  7. Uveitis or history of uveitis.
  8. Retinal pigment epithelium tear in the fovea of the injected eye.
  9. Vitreous hemorrhage
  10. Conjunctivitis, keratitis, scleritis, endophthalmitis.
  11. Intraocular surgery (including cataract) within two months
  12. Uncontrolled glaucoma (IOP≥30 mmHg under glaucoma medications)
  13. Hypertension treated with two or more medication
  14. History of myocardial infarct
  15. History of myocardial insufficiency -
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Please refer to this study by its identifier: NCT00478530

Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: YGAL ROTENSTREICH Sheba Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ygal Rotenstreich, Sheba Medical Center Identifier: NCT00478530     History of Changes
Other Study ID Numbers: SHEBA-07-4573-YR-CTIL
Study First Received: May 24, 2007
Last Updated: February 4, 2009

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on August 23, 2017