Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

Sponsor

Khon Kaen University (Other)

Overall Status

Completed

CT.gov ID

NCT01724385

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Vitreous Hemorrhage Proliferative Diabetic Retinopathy	Drug: intravitreal injection of bevacizumab	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intravitreal bevacizumab injection intravitreal injection of bevacizumab 1.25 mg	Drug: intravitreal injection of bevacizumab intravitreal injection of bevacizumab Other Names: Avastin

Arm

Intervention/Treatment

Experimental: intravitreal bevacizumab injection

intravitreal injection of bevacizumab 1.25 mg

Drug: intravitreal injection of bevacizumab

intravitreal injection of bevacizumab

Other Names:

Avastin

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Numbers of injection [12 months]
Numbers of intravitreous bevacizumab injection in a 12-month period

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.