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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2007

Last Updated Date

February 4, 2009

Start Date ^ICMJE

May 2007

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

electroretinogram responses [ Time Frame: before treatment and one month after treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

electroretinogram responses

Change History

Complete list of historical versions of study NCT00478530 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

Official Title ^ICMJE

The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Macular Degeneration

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

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. Epub 2007 Feb 15.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 -

Gender

Both

Ages

50 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00478530

Other Study ID Numbers ^ICMJE

SHEBA-07-4573-YR-CTIL

Has Data Monitoring Committee

Responsible Party

Ygal Rotenstreich, Sheba Medical Center

Study Sponsor ^ICMJE

Sheba Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

YGAL ROTENSTREICH

Sheba Medical Center

Information Provided By

Sheba Medical Center

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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