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

Primary Purpose

Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy, Diabetic Macular Edema

Status
Completed
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
King Khaled Eye Specialist Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-proliferative Diabetic Retinopathy focused on measuring Peripheral retinal ischemia, ultra wide field fluorescein angiography, Bevacizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King Khaled Eye Specialist Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bevacizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 24, 2014
Last Updated
December 2, 2021
Sponsor
King Khaled Eye Specialist Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02096874
Brief Title
Bevacizumab and Peripheral Retinal Changes on Wide Field Angiography in Diabetic Macular Edema
Official Title
The Effect of Bevacizumab on Peripheral Retinal Changes as Imaged by Wide -Field Fluorescein Angiography in Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Khaled Eye Specialist Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-proliferative Diabetic Retinopathy, Proliferative Diabetic Retinopathy, Diabetic Macular Edema
Keywords
Peripheral retinal ischemia, ultra wide field fluorescein angiography, Bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Intravitreal injection of 1.25mg/0.05 cc each 5 weeks for the first 3 months then PRN for six month
Primary Outcome Measure Information:
Title
Peripheral retinal ischemia
Description
Change in peripheral retinal ischemia after intravitreal bevacizumab injection in non proliferative diabetic retinopathy and proliferative diabetic retinopathy.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saba al Rashaed, MD
Organizational Affiliation
King Khaled Eye Specialist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Khaled Eye Specialist Hospital
City
Riyadh
ZIP/Postal Code
11462
Country
Saudi Arabia

12. IPD Sharing Statement

Learn more about this trial

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

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