Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

NCT ID: NCT01724385

Last Updated: 2013-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-12-31

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.

Conditions

Vitreous Hemorrhage; Proliferative Diabetic Retinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intravitreal bevacizumab injection

intravitreal injection of bevacizumab 1.25 mg

Group Type: EXPERIMENTAL

intravitreal injection of bevacizumab

Intervention Type: DRUG

intravitreal injection of bevacizumab

Interventions

intravitreal injection of bevacizumab

intravitreal injection of bevacizumab

Intervention Type: DRUG

Other Intervention Names

Avastin

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Yosanan Yospaiboon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suthasinee Sinawat, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

Locations

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, Thailand

Countries

Thailand

Other Identifiers

I55116

Identifier Type: -

Identifier Source: org_study_id