Anterior and Posterior Segment Vascular Changes Following Laser and Anti-Vascular Endothelial Growth Factor (VEGF) Treatment of Diabetic Retinopathy (VEGF)
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|ClinicalTrials.gov Identifier: NCT01196325|
Recruitment Status : Unknown
Verified January 2013 by Chris Hudson, University of Toronto.
Recruitment status was: Recruiting
First Posted : September 8, 2010
Last Update Posted : January 24, 2013
|Condition or disease|
|Diabetic Macular Edema|
Diabetic Retinopathy (DR) is the single leading cause of blindness in people of working age. The total number of people living with diabetes in Canada is well over 2 million. The WHO estimates that around 12% of people with diabetes are blind or will develop severe vision loss. The two most common treatments of DR are: Laser Photocoagulation and anti-VEGF intravitreal injection. Clinical evidence demonstrates that these treatments lead to morphological and vascular retinal changes, however the actual mechanism and nature of post treatment changes is not fully understood. It is only recently that objective and quantitative imaging and hemodynamic technologies with previously unachievable resolution have become available that enable us to evaluate and to compare various effects of these treatments on vital eye structures.
We are proposing to take advantage of these state-of-the-art technologies in order to explore unknown effects of treatments on vital eye structures. We hypothesize that: 1) Laser Photocoagulation and anti-VEGF treatments will result in vessel constriction and hence reduction in posterior (retinal and choroidal) and anterior (conjunctival) ocular blood flow; 2) Changes in anterior segment ocular morphology and blood flow will positively correlate with changes in posterior segment morphology and blood flow; 3) Combined treatments will result in a greater reduction in posterior and anterior blood flow than any single treatment; 4) There will be differences in anterior and posterior blood flow outcomes and in anterior segment oxygen saturation when compared to healthy controls.
The study will include four groups of participants: Laser treatment group; Intravitreal injection of Bevacizumab treatment group; Intravitreal injection of Ranibizumab treatment group; Healthy age matched controls. The administration of ranibizumab and bevacizumab will be randomized across participants. Randomization number will be assigned to each participant and recorded in a Master Randomization Assignment List. All patients will be recruited from the Retina Clinics of the Toronto Western Hospital.
Every type 2 diabetic patient with Diabetic Macular Edema will be assessed prior to treatment and followed-up on the 3rd, 7th,30th day and 3 months after the initial treatment.
|Study Type :||Observational|
|Estimated Enrollment :||64 participants|
|Official Title:||Anterior and Posterior Segment Vascular Changes Following Laser and Anti-Vascular Endothelial Growth Factor (VEGF) Treatment of Diabetic Retinopathy.|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2014|
Patients who are clinically indicated for the laser treatment
Anti-VEGF Group (Bevacizumab)
Patients who are clinically indicated for the intravitreal injection of Bevacizumab
Anti-VEGF Group (Ranibizumab)
Patients who are clinically indicated for intravitreal injection of Ranibizumab
Group of non-diabetic participants who will be age and gender matched
- Quantitative inner retinal blood flow [ Time Frame: Baseline, 3, 7, 30 days and 3 months ]Inner retinal blood flow will be measured using Canon Laser Blood Flowmeter
- Mean retinal thickness for an annulus centered on fovea [ Time Frame: Baseline,3,7,30 days, and 3 months ]Mean retinal thickness will be measured using Heidelberg Spectralis Spectral Domain Optical Coherence Tomography
- Best Corrected Visual Acuity (LogMAR, EDTRS) [ Time Frame: Baseline, 3, 7, 30 days and 3 months ]Best Corrected Visual Acuity will be examined using 96% and 10 % contrast EDTRS letter charts.
- Quantitative anterior blood flow [ Time Frame: Baseline, 3, 7, 30 days and 3 months ]Quantitative anterior blood flow will be assessed by measuring velocity of individual rbc's (μm/sec) and blood oxygen saturation(%)
- Mean angle opening distance and trabecular-iris spur area [ Time Frame: Baseline, 3, 7, 30 days and 3 months ]Mean angle opening distance and trabecular-iris spur area will be measured by Heidelberg Slit-Lamp Optical Coherence Tomography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196325
|Contact: Olena Puzyeyeva, MD||(416)603-5694 ext email@example.com|
|Contact: Lee-Anne Khuu, MSc||(416)603-5694 ext firstname.lastname@example.org|
|Toronto Western Hospital||Recruiting|
|Toronto, Ontario, Canada, M5T2S8|
|Contact: Olena Puzyeyeva, MD (416)603-5694 email@example.com|
|Contact: Lee-Anne Khuu, MSc (416)603-5694 firstname.lastname@example.org|
|Principal Investigator: Christopher Hudson, PhD|
|Sub-Investigator: Michael Brent, MD|
|Sub-Investigator: John G Flanagan, PhD|
|Sub-Investigator: Wai-Ching Lam, MD|
|Sub-Investigator: Robert G Devenyi, MD|
|Sub-Investigator: Mark Mandelcorn, MD|
|Sub-Investigator: Efrem Mandelcorn, MD|
|Principal Investigator:||Christopher Hudson, PhD||University of Toronto|