Anterior and Posterior Segment Vascular Changes Following Laser and Anti-Vascular Endothelial Growth Factor (VEGF) Treatment of Diabetic Retinopathy

NCT01196325 | Unknown

• 1 other identifier: 09-0258-BE
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Macular Edema

Keywords

Diabetes; Diabetic Macular Edema; Laser; Anti-VEGF; Morphology; Blood Flow; Vision

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (4)

Laser Group

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

Age-matched controls

Group of non-diabetic participants who will be age and gender matched

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetic patients with clinically sight-threatening Diabetic Macular Edema will be recruited from the Retina Clinics of Toronto Western Hospital.

You may qualify if:

• Age range of 35-75 yrs
• Type 2 diabetes apart from age-matched control group
• Visual acuity of 20/400 or better
• Confirmed diagnose of Clinical Significant Diabetic Macular Edema (applies for Diabetic Groups only)
• Previously untreated eye for retinal diseases and disorders

You may not qualify if:

• Distance refractive error \> ± 6.00 DS \& / or ± 2.50 DC
• Intraocular pressure ≥ 22mm Hg
• Proliferative Diabetic Retinopathy
• Any other active eye disease and disorder
• Participants with history of cardiovascular events, stroke, thromboembolic events, transient ischemic attack, uncontrolled hypertension.
• Any active ocular infection;
• History of glaucoma;
• Known allergy, hypersensitivity or contraindication to the study medication;
• Pregnancy, breast feeding, or women of childbearing potential who are not using a reliable method of contraception;
• Proteinuria and/or renal impairment;
• Surgery within the past 28 days.

Sponsors & Collaborators

• University of Toronto: lead
• Ontario Research Fund: collaborator

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christopher Hudson, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olena Puzyeyeva, MD

CONTACT

(416)603-5694; opuzyeye@uhnresearch.ca

Lee-Anne Khuu, MSc

CONTACT

(416)603-5694; lkhuu@uhnresearch.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 8, 2010
• Study Start: July 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

CA (1)