The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00478530
First received: May 24, 2007
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

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: 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 ] [ Designated as safety issue: Yes ]

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:
    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
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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478530

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

Publications:
Responsible Party: Ygal Rotenstreich, Sheba Medical Center
ClinicalTrials.gov 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
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014