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Completed

NCT Number: NCT02096874

Bevacizumab and Peripheral Retinal Changes on Wide Field Angiography in Diabetic Macular Edema

Ultra-wide field fluorescein angiography can detect the response of anti VGEF therapy such as Avastin on retinal ischemia in the setting of diabetic macular edema.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King Khaled Eye Specialist Hospital

Riyadh, 11462, Saudi Arabia

About this study

The major causes of vision loss in diabetic retinopathy are diabetic macular edema (DME) characterized by thickening of the macula due to abnormal leakage of the retinal vasculature. Ischaemic changes and microvascular pathologies have long been hypothesized to play a role in the development of DME. In diabetic retinopathy, ischaemia stimulates the production of vascular endothelial growth factor (VEGF), which can lead to the breakdown of blood-retinal barriers, and may cause DME through an increase in retinal vessel permeability. DME is best evaluated by optical coherence tomography (OCT) while retinal ischemia is determined by Fluorescein angiography. With the avaiability of ultra wide field fluorescein angiography, the investigators can now accurately measure the degree of ischemia in peripheral retina. Thus, this study will provide us data on the degree of retinal ischemia in nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) cases as well as the measurable change that occurs in retinal ischemia after intra vitreal injection of bevacizumab.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diabetic patients at age >18year with DME
  • Scheduled for Avastin therapy
  • Adequate media to obtain OCT and UWFA

Exclusion criteria

  • Macular pathology of any etiology
  • Preexisting systemic disease causing retinal ischemia
  • Previous laser or anti-VEGF treatment in past 3 months
  • Previous retina surgery in past 2 months
  • Allergy to fluorescein dye
  • Psychiatric disorder, Alzheimer disease and Dementia or any other disorder precluding follow-up or continuation of the study.

Treatment and study plan

Bevacizumab

Drug

Intravitreal injection of 1.25mg/0.05 cc each 5 weeks for the first 3 months then PRN for six month

Other names: Avastin

Primary outcomes

  1. Peripheral retinal ischemia

    Time frame: 24 weeks

    Change in peripheral retinal ischemia after intravitreal bevacizumab injection in non proliferative diabetic retinopathy and proliferative diabetic retinopathy.

Sponsors and collaborators

Lead sponsor

King Khaled Eye Specialist Hospital

Other Gov

Registry information

Official study title

The Effect of Bevacizumab on Peripheral Retinal Changes as Imaged by Wide -Field Fluorescein Angiography in Diabetic Macular Edema

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Mar 26, 2014
Registry last updated
Dec 3, 2021

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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