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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096874
• Other study ID #: RP 1310
• Status: Completed
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2021
• Source: King Khaled Eye Specialist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema
• Non-proliferative Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	King Khaled Eye Specialist Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Khaled Eye Specialist Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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