Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

April 25, 2013 updated by: Yosanan Yospaiboon, Khon Kaen University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital, Khon Kaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of eyes that vitreous hemorrhage has been completely resolved
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in best corrected visual acuity (BCVA) from baseline
Time Frame: 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.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers of injection
Time Frame: 12 months
Numbers of intravitreous bevacizumab injection in a 12-month period
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Suthasinee Sinawat, M.D., Department of Ophthalmology, Faculty of medicine, Khon Kaen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

November 7, 2012

First Submitted That Met QC Criteria

November 8, 2012

First Posted (ESTIMATE)

November 9, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 26, 2013

Last Update Submitted That Met QC Criteria

April 25, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I55116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Proliferative Diabetic Retinopathy

Clinical Trials on intravitreal injection of bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe