Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

Phase 4

Completed

• Conditions: Vitreous Hemorrhage; Proliferative Diabetic Retinopathy
• Interventions: Drug: intravitreal injection of bevacizumab

• Registration Number: NCT01724385
• Lead Sponsor: Khon Kaen University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-11-07
• Study First Submitted QC: 2012-11-08
• Study First Posted: 2012-11-09
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intravitreal bevacizumab injection	intravitreal injection of bevacizumab	intravitreal injection of bevacizumab 1.25 mg

Primary Outcome Measures

Name	Time	Method
The percentage of eyes that vitreous hemorrhage has been completely resolved	12 months	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.

Secondary Outcome Measures

Name	Time	Method
The change in best corrected visual acuity (BCVA) from baseline	12 months	The best corrected visual acuity (BCVA) was performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.

Trial Locations

Locations (1)

Srinagarind Hospital, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand