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

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Ranibizumab Ophthalmic

• Registration Number: NCT02979665
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-11-25
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-01
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ranibizumab Ophthalmic	Ranibizumab Ophthalmic	DME consults requiring anti-VEGF treatment

Primary Outcome Measures

Name	Time	Method
Effects of anti-VEGF drugs on intraocular pressure (mmHg)	2 year

Secondary Outcome Measures

Name	Time	Method
Effects of anti-VEGF drugs on macular thickness (um)	2 year