The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

Macular Degeneration Clinical Trial

Official title:

The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478530
• Other study ID #: SHEBA-07-4573-YR-CTIL
• Status: Completed
• Phase: N/A
• First received: May 24, 2007
• Last updated: February 4, 2009
• Start date: May 2007
• Est. completion date: October 2008

Study information

• Verified date: February 2009
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 -

Study Design

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

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	electroretinogram responses		before treatment and one month after treatment	Yes