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The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ELECTRORETINOGRAM
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Sheba Medical Center

Outcomes

Primary Outcome Measures

electroretinogram responses

Secondary Outcome Measures

Full Information

First Posted
May 24, 2007
Last Updated
February 4, 2009
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00478530
Brief Title
The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram
Official Title
The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
ELECTRORETINOGRAM
Intervention Description
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
Primary Outcome Measure Information:
Title
electroretinogram responses
Time Frame
before treatment and one month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who were diagnosed with CNV caused by ARMD ERG can be performed in both eyes Exclusion Criteria: Treatment within 7 days with VERTOPROFIN Treatment within one month with laser photocoagulation Ocular surgery for AMD (besides laser). Participation in other medical study Sub-fovea RPE atrophy in the study eye. CNV with ocular histoplasmosis, trauma, pathological myopia. Uveitis or history of uveitis. Retinal pigment epithelium tear in the fovea of the injected eye. Vitreous hemorrhage Conjunctivitis, keratitis, scleritis, endophthalmitis. Intraocular surgery (including cataract) within two months Uncontrolled glaucoma (IOP≥30 mmHg under glaucoma medications) Hypertension treated with two or more medication History of myocardial infarct History of myocardial insufficiency -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YGAL ROTENSTREICH
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
17306753
Citation
Pai SA, Shetty R, Vijayan PB, Venkatasubramaniam G, Yadav NK, Shetty BK, Babu RB, Narayana KM. Clinical, anatomic, and electrophysiologic evaluation following intravitreal bevacizumab for macular edema in retinal vein occlusion. Am J Ophthalmol. 2007 Apr;143(4):601-6. doi: 10.1016/j.ajo.2006.12.037. Epub 2007 Feb 15.
Results Reference
background
PubMed Identifier
19955196
Citation
Rotenstreich Y, Harats D, Shaish A, Pras E, Belkin M. Treatment of a retinal dystrophy, fundus albipunctatus, with oral 9-cis-beta-carotene. Br J Ophthalmol. 2010 May;94(5):616-21. doi: 10.1136/bjo.2009.167049. Epub 2009 Dec 2.
Results Reference
derived

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The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

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