Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy

Study Overview
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Brief Summary
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Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard exudates secondary to diabetic retinopathy. Design: Prospective interventional case series. Participants: Ten eyes of 10 consecutive patients showing focal edema with hard exudates secondary to diabetic retinopathy which are not eligible for focal laser photocoagulation due to central location (< 500 µm from fovea).

Conditions
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Diabetes Complications

Intervention / Treatment
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* Drug: Avastin (bevacizumab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients of either gender aged > 18 years patients with type 2 diabetes central macular thickness > 300 µm on OCT eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (< 500 µm) an area of retinal thickening less than 2 disc areas in diameter 67% or more of leakage associated with microaneurysms Exclusion Criteria: eyes with history of laser photocoagulation or pharmacological intervention for DME on study eye eyes with any pharmacologic intervention on fellow eye within 6 months history of ocular diseases other than diabetic retinopathy surgical history other than cataract extraction with intraocular lens implantation panretinal photocoagulation within 3 months of enrollment media opacity any thromboembolic event within 6 months, or evidence of active cardiac ischemia on electrocardiogram (ECG) at time of screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one arm for Anastin injection<br>intravitreal Avastin injection | Drug: Avastin (bevacizumab)<br>* Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in best-corrected visual acuity (BCVA) | ETDRS BCVA will be measured after 6 6 serial IVB. | from month 0 to month 6 in monthly schedule (upto 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of hard exudates detected on fundus photography | on fundus photography | from month 0 to month 6 in bimonthly schedule (upto 6 months) | 
| macular edema detected by optical coherent tomography | central subfield thickness will be measured. | from month 0 to month 6 in bimonthly schedule (upto 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinically significant macular edema, diabetic macular edema, focal edema, focal laser photocoagulation, hard exudates, intravitreal bevacizumab