Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yosanan Yospaiboon, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01724385
First received: November 7, 2012
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Vitreous Hemorrhage
Proliferative Diabetic Retinopathy
Drug: intravitreal injection of bevacizumab
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy With New Dense Vitreous Hemorrhage After Full Panretinal Photocoagulation

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • The percentage of eyes that vitreous hemorrhage has been completely resolved [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Numbers of intravitreous bevacizumab injection in a 12-month period


Enrollment: 18
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intravitreal bevacizumab injection
intravitreal injection of bevacizumab 1.25 mg
Drug: intravitreal injection of bevacizumab
intravitreal injection of bevacizumab
Other Name: Avastin

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01724385     History of Changes
Other Study ID Numbers: I55116
Study First Received: November 7, 2012
Last Updated: April 25, 2013
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by 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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014