Status:

UNKNOWN

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

Lead Sponsor:

University of Toronto

Collaborating Sponsors:

Ontario Research Fund

Conditions:

Diabetic Macular Edema

Eligibility:

All Genders

35-75 years

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. ...

Detailed Description

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 ar...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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.

Key Trial Info

Start Date :

July 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2014

Estimated Enrollment :

64 Patients enrolled

Trial Details

Trial ID

NCT01196325

Start Date

July 1 2009

End Date

August 1 2014

Last Update

January 24 2013

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Toronto Western Hospital

Toronto, Ontario, Canada, M5T2S8