Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of the Adjunctive IVB Before PRP (IVB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Hospital

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

Layout table for study information
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

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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
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
Layout table for location information
Korea, Republic of
Dong Ho Park
Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Dong Ho Park, M.D. Kyungpook National University Hospital

Publications:
Layout table for additonal information
Responsible Party: Dong Ho Park, Clinical professor, Kyungpook National University Hospital
ClinicalTrials.gov Identifier: NCT01504724    
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 Hospital:
central macular thickness
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors