The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 24, 2007
CompletedFirst Posted
Study publicly available on registry
May 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFebruary 5, 2009
February 1, 2009
1.1 years
May 24, 2007
February 4, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
electroretinogram responses
before treatment and one month after treatment
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients who were diagnosed with CNV caused by ARMD
- ERG can be performed in both eyes
You may not qualify if:
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Ramat Gan, 52621, Israel
Related Publications (2)
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.
PMID: 17306753BACKGROUNDRotenstreich 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.
PMID: 19955196DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
YGAL ROTENSTREICH
Sheba Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
May 24, 2007
First Posted
May 25, 2007
Study Start
May 1, 2007
Primary Completion
June 1, 2008
Study Completion
October 1, 2008
Last Updated
February 5, 2009
Record last verified: 2009-02