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

NCT ID: NCT02096874

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Non-proliferative Diabetic Retinopathy Proliferative Diabetic Retinopathy Diabetic Macular Edema

Keywords

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Peripheral retinal ischemia ultra wide field fluorescein angiography Bevacizumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Bevacizumab

Intervention Type DRUG

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

Interventions

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Bevacizumab

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

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Khaled Eye Specialist Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saba al Rashaed, MD

Role: PRINCIPAL_INVESTIGATOR

King Khaled Eye Specialist Hospital

Locations

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King Khaled Eye Specialist Hospital

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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RP 1310

Identifier Type: -

Identifier Source: org_study_id