Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724385
• Other study ID #: I55116
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2012
• Last updated: April 25, 2013
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Hemorrhage
• Proliferative Diabetic Retinopathy
• Retinal Diseases
• Vitreous Hemorrhage

Intervention

Drug:
• intravitreal injection of bevacizumab
intravitreal injection of bevacizumab

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital, Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numbers of injection	Numbers of intravitreous bevacizumab injection in a 12-month period	12 months	No
Primary	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	No
Secondary	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	No