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

Phase 4

Completed

• Conditions: Non-proliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy; Diabetic Macular Edema
• Interventions: Drug: Bevacizumab

• Registration Number: NCT02096874
• Lead Sponsor: King Khaled Eye Specialist Hospital

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-26
• Primary Completion: 2014-12
• Study Completion: 2015-06
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab	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.

Primary Outcome Measures

Name	Time	Method
Peripheral retinal ischemia	24 weeks	Change in peripheral retinal ischemia after intravitreal bevacizumab injection in non proliferative diabetic retinopathy and proliferative diabetic retinopathy.

Trial Locations

Locations (1)

King Khaled Eye Specialist Hospital; 🇸🇦 Riyadh, Saudi Arabia