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Completed

NCT Number: NCT00478530

The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Ramat Gan, 52621, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

ELECTRORETINOGRAM

Procedure

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 outcomes

  1. electroretinogram responses

    Time frame: before treatment and one month after treatment

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 25, 2007
Registry last updated
Feb 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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