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OpenTrials
Completed

NCT Number: NCT02979665

Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema

anti-VEGF therapy is an established method to control leakage and abnormal growth of retinal blood vessels. Questions on the long-term effect on the retina, intraocular pressure and on the overall retinal perfusion from these treatments remain to be answered. The purpose of the study was to evaluate changes in the retina following anti-VEGF treatment over time, using structural and functional diagnostic tests.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Diabetic retinopathy (DR) causes changes in the capillaries that nourish the retina. Two treatments clinically used for DR are laser photocoagulation to reduce the angiogenic drive by knocking off metabolically active retina and anti-VEGF drugs for diabetic macular edema (DME). DME affects approximately 2.5% of the nearly 2.4 million Canadians with diabetes, or approximately 60,000 Canadians, making it a major cause of adult-onset vision loss. DME occurs when blood vessels in the retina of diabetic patients become leaky resulting in unwanted fluid accumulation in the center of vision known as the macula. If not treated, this can lead to blindness. Originally used in the treatment of age-related macular degeneration (AMD), anti-VEGF drugs are increasingly used to control leakage and abnormal growth of retinal blood vessels. Numerous questions have emerged following the usage of anti-VEGF medications in the eye such as their long-term effects of these drugs on intraocular pressure and on the overall retinal perfusion. By recruiting DR patients requiring anti-VEGF treatment for DME, this study will answer whether long-term usage of anti-VEGF will result in structural and functional changes to the retina.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DME patients
  • Require anti-VEGF injections in at least one eye

Exclusion criteria

  • Advanced lens opacity or cataract that could affect diagnostic testing
  • Prior retinal treatment (PRP, focal laser or surgery within 6 months of participation)

Treatment and study plan

Ranibizumab Ophthalmic

Drug

Ranibizumab (trade name Lucentis among others) is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that has been approved to treat the "wet" type of age-related macular degeneration (AMD, also ARMD), a common form of age-related vision loss and diabetic macular edema (DME).

Other names: Lucentis

Primary outcomes

  1. Effects of anti-VEGF drugs on intraocular pressure (mmHg)

    Time frame: 2 year

Secondary outcomes

  1. Effects of anti-VEGF drugs on macular thickness (um)

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

A Clinico-Pathological Study of the Structural and Functional Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2016
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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