Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

Study Overview
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Brief Summary
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To evaluate the efficacy of intravitreal bevacizumab injections for treatment of proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after previous full panretinal photocoagulation (PRP).

Detailed Description
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The investigators will carry out a prospective study in patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes will be treated with intravitreal injection of bevacizumab (1.25 mg). Complete ophthalmic examination and/or ocular ultrasonography will be performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. Re-injection will be done in non-clearing and recurrent VH.

Official Title
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Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy With New Dense Vitreous Hemorrhage After Full Panretinal Photocoagulation

Conditions
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Vitreous Hemorrhage, Proliferative Diabetic Retinopathy

Intervention / Treatment
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* Drug: intravitreal injection of bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with diabetes mellitus proliferative diabetic retinopathy prior complete panretinal photocoagulation presented with new dense vitreous hemorrhage Exclusion Criteria: one-eyed patient previous intraocular surgery severe lens opacity precluding fundus examination advance glaucoma history of thromboembolic events such as myocardial infarction and cerebrovascular accident uncontrolled systemic hypertension, systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg known coagulation abnormalities or current use of anticoagulant medications other than aspirin known allergies to any relevant drugs in this study evidence of external ocular infection such as conjunctivitis and significant blepharitis.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: intravitreal bevacizumab injection<br>intravitreal injection of bevacizumab 1.25 mg | Drug: intravitreal injection of bevacizumab<br>* intravitreal injection of bevacizumab<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of eyes that vitreous hemorrhage has been completely resolved | The patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes were treated with intravitreal bevacizumab injection. Complete ophthalmic examination and/or ocular ultrasonography were performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in best corrected visual acuity (BCVA) from baseline | The best corrected visual acuity (BCVA) was performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bevacizumab,, proliferative diabetic retinopathy,, vitreous hemorrhage,