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

December 2, 2021 updated by: King Khaled Eye Specialist Hospital

The Effect of Bevacizumab on Peripheral Retinal Changes as Imaged by Wide -Field Fluorescein 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11462
        • King Khaled Eye Specialist Hospital

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Bevacizumab
Each study subject will recieve Intravitreal injection of 1.25mg/0.05 cc each 5 weeks for the first 3 months then PRN for six month.
Drug: Bevacizumab
Intravitreal injection of 1.25mg/0.05 cc each 5 weeks for the first 3 months then PRN for six month
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Collaborators and Investigators

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

Sponsor

King Khaled Eye Specialist Hospital

Investigators

  • Principal Investigator: Saba al Rashaed, MD, King Khaled Eye Specialist Hospital

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 (Actual)

June 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP 1310

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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