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

April 30, 2019 updated by: Lawson Health Research Institute

A Clinico-Pathological Study of the Structural and Functional 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

51

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

DR consults referred to the Ivey Eye Institute and requiring anti-VEGF injections in at least one eye due to DME will be recruited into the study.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ranibizumab Ophthalmic
DME consults requiring anti-VEGF treatment
Drug: Ranibizumab Ophthalmic
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
Control
DME consults not requiring anti-VEGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects of anti-VEGF drugs on intraocular pressure (mmHg)
Time Frame: 2 year
2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Effects of anti-VEGF drugs on macular thickness (um)
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Cindy Hutnik, MD, PhD, St. Joseph's Health Care London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

August 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

November 25, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (ESTIMATE)

December 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105570

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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