Clinical trial NCT00478530: 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
Overall status: COMPLETED
Phase: NA
Conditions: Macular Degeneration
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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 -

Primary outcomes:
measure: electroretinogram responses
timeFrame: before treatment and one month after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: YGAL ROTENSTREICH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.