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Effect of the Adjunctive IVB Before PRP (IVB)

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ClinicalTrials.gov Identifier: NCT01504724
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University

Brief Summary:
This study is to investigate the effect of adjunctive intravitreal bevacizumab (IVB) before panretinal photocoagulation (PRP) compared with only PRP on central macular thickness and retinal nerve fiber layer thickness in patients with severe diabetic retinopathy without macular edema.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: bevacizumab Phase 4

Detailed Description:
This prospective randomized study included 30 patients (60 eyes) with severe nonproliferative diabetic retinopathy or non-high-risk proliferative diabetic retinopathy. They had weekly PRP treatments in 3 sessions and they were randomly assigned to IVB group who had adjunctive IVB within 1 week before first PRP and control group who had only PRP. CMT, RNFL, and best-corrected visual acuity (BCVA) were measured

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Adjunctive Intravitreal Bevacizumab Before Panretinal Photocoagulation in Macular Thickness and Retinal Nerve Fiber Layer Thickness
Study Start Date : August 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: IVB group
Patients were treated with IVB injections approximately within 1 week before the first PRP. Then patients had PRP, which was done in three sessions at weeks 0, 1, and 2 according to ETDRS guidelines. The superior, inferior, and nasal and temporal areas were treated sequentially.
Drug: bevacizumab
intravitreal bevacizumab injection (1.25 mg/0.05 mL) was done 4.0 mm posterior to the corneal limbus using a 30-gauge needle after topical anesthesia
Other Name: Avastin; Genentech, Inc., South San Francisco, CA, USA
No Intervention: only PRP group
Patients had PRP, which was done in three sessions at weeks 0, 1, and 2 according to ETDRS guidelines. The superior, inferior, and nasal and temporal areas were treated sequentially.



Primary Outcome Measures :
  1. Central macular thickness [ Time Frame: 6 months after first PRP session ]
    central macular thickness measured by Cirrus HD optical coherence tomography


Secondary Outcome Measures :
  1. Retinal nerve fiber layer thickness [ Time Frame: 6 months after first PRP session ]
    retinal nerve fiber layer thickness measured by Cirrus HD optical coherence tomography.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with severe NPDR or early PDR without macular edema
  • best-corrected visual acuity (BCVA) of 20/25 or better
  • patients who were followed up for at least 6 months after the first PRP.

Exclusion Criteria:

  • patients with retinal or choroidal diseases except diabetic retinopathy
  • contraindications to fluorescein angiography (FA) or bevacizumab
  • patients who had previous treatments including anti-angiogenic medications and laser photocoagulation
  • patients with previous vitrectomy
  • patients with uncontrolled hypertension, a recent myocardial infarction or cerebral vascular accidents.

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): NCT01504724


Locations
Korea, Republic of
Dong Ho Park
Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University
Investigators
Principal Investigator: Dong Ho Park, M.D. Kyungpook National University

Publications:
Responsible Party: Dong Ho Park, Clinical professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01504724     History of Changes
Other Study ID Numbers: IVB and PRP
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: December 25, 2013
Last Verified: December 2013

Keywords provided by Dong Ho Park, Kyungpook National University:
central macular thickness

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