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Effect of the Adjunctive IVB Before PRP

This study is currently recruiting participants.
Verified January 2012 by Kyungpook National University
Sponsor:
Information provided by (Responsible Party):
Dong Ho Park, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01504724
First received: January 1, 2012
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Diabetic Retinopathy
 Drug: bevacizumab
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Adjunctive Intravitreal Bevacizumab Before Panretinal Photocoagulation in Macular Thickness and Retinal Nerve Fiber Layer Thickness

Resource links provided by NLM:

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

Further study details as provided by Kyungpook National University:

Primary Outcome Measures:
  • Central macular thickness [ Time Frame: 6 months after first PRP session ] [ Designated as safety issue: No ]
    central macular thickness measured by Cirrus HD optical coherence tomography


Secondary Outcome Measures:
  • Retinal nerve fiber layer thickness [ Time Frame: 6 months after first PRP session ] [ Designated as safety issue: No ]
    retinal nerve fiber layer thickness measured by Cirrus HD optical coherence tomography.


Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504724

Contacts
Contact: Dong Ho Park, M.D. 82534205813 Sarasate@hitel.net

Locations
Korea, Republic of
Dong Ho Park Recruiting
Daegu, Korea, Republic of, 700-721
Contact: Dong Ho Park, M.D.     82534205813     Sarasate@hitel.net    
Principal Investigator: Dong Ho Park, M.D.            
Sponsors and Collaborators
Kyungpook National University
Investigators
Principal Investigator: Dong Ho Park, M.D. Kyungpook National University
  More Information

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
Study First Received: January 1, 2012
Last Updated: January 4, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013