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

King Khaled Eye Specialist Hospital

Status and phase: Completed; Phase 4

Conditions: Non-proliferative Diabetic Retinopathy; Diabetic Macular Edema; Proliferative Diabetic Retinopathy

Treatments: Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02096874

RP 1310

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Bevacizumab

Other group

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.

Treatment:

Drug: Bevacizumab