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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02096874

Enrollment

Registered

2014-03-26

Start date

2013-06-30

Completion date

2015-06-30

Last updated

2021-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Peripheral retinal ischemia, ultra wide field fluorescein angiography, Bevacizumab

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.

Interventions

DRUGBevacizumab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Peripheral retinal ischemia	24 weeks	Change in peripheral retinal ischemia after intravitreal bevacizumab injection in non proliferative diabetic retinopathy and proliferative diabetic retinopathy.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026