NCT01196325|Unknown
Anterior and Posterior Segment Vascular Changes Following Laser and Anti-Vascular Endothelial Growth Factor (VEGF) Treatment of Diabetic Retinopathy
VEGF
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VEGF
Sponsor study identifier
observational
64
1 country
1
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The study will investigate changes in the structure and function of blood vessels in the front and back of the eye following laser and anti-VEGF treatments for sight-threatening diabetic eye disease. Sixty four volunteers will be recruited, including age-matched control subjects and diabetic patients who require conventional or contemporary treatment for pre-existing diabetic eye disease. Volunteers will be assessed before and after treatment using state-of-the-art techniques to measure vision, the rate of blood flow and structure at the front and back of the eye and the effectiveness of blood flow delivery. Changes following treatment in these novel, non-invasive techniques will be quantified and described. We anticipate that conventional and new / developing treatments will lead to narrowing of the vessels and consequent reduction of blood flow at the back and front of the eye. There will be a strong relationship between structural changes of the eye and functional changes of blood vessels at the front and back of the eye. The results of this study will improve our understanding of the impact of the various treatments on the entire eye. The research will also ensure an improved understanding of the mechanisms of action of the various treatments and will provide insight of reasons for good or poor outcomes, based upon specific changes in structure and blood flow.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
September 3, 2010
Actual (reported)September 8, 2010
Actual (reported)August 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Quantitative inner retinal blood flow
Inner retinal blood flow will be measured using Canon Laser Blood Flowmeter
Baseline, 3, 7, 30 days and 3 months
Mean retinal thickness for an annulus centered on fovea
Baseline,3,7,30 days, and 3 months
Best Corrected Visual Acuity (LogMAR, EDTRS)
Baseline, 3, 7, 30 days and 3 months
Quantitative anterior blood flow
Baseline, 3, 7, 30 days and 3 months
Mean angle opening distance and trabecular-iris spur area
Baseline, 3, 7, 30 days and 3 months
Patients who are clinically indicated for the laser treatment
Patients who are clinically indicated for the intravitreal injection of Bevacizumab
Patients who are clinically indicated for intravitreal injection of Ranibizumab
Group of non-diabetic participants who will be age and gender matched
Type 2 diabetic patients with clinically sight-threatening Diabetic Macular Edema will be recruited from the Retina Clinics of Toronto Western Hospital.
Toronto Western Hospital
Toronto, Ontario, M5T2S8, Canada
Christopher Hudson, PhD
University of Toronto
First Submitted
September 3, 2010
First Posted
September 8, 2010
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2014
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 24, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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