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Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT01724385
Recruitment Status : Completed
First Posted : November 9, 2012
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
Actual Enrollment : 18 participants
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 : August 2012
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

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 Name: Avastin


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Numbers of injection [ Time Frame: 12 months ]
    Numbers of intravitreous bevacizumab injection in a 12-month period


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724385


Locations
Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Suthasinee Sinawat, M.D. Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
More Information

Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01724385     History of Changes
Other Study ID Numbers: I55116
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Yosanan Yospaiboon, Khon Kaen University:
bevacizumab,
proliferative diabetic retinopathy,
vitreous hemorrhage,

Additional relevant MeSH terms:
Hemorrhage
Retinal Diseases
Diabetic Retinopathy
Vitreous Hemorrhage
Pathologic Processes
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Hemorrhage
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents