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Effect of the Adjunctive IVB Before PRP (IVB)

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
bevacizumab
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring central macular thickness

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dong Ho Park

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IVB group

only PRP group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Central macular thickness
central macular thickness measured by Cirrus HD optical coherence tomography

Secondary Outcome Measures

Retinal nerve fiber layer thickness
retinal nerve fiber layer thickness measured by Cirrus HD optical coherence tomography.

Full Information

First Posted
January 1, 2012
Last Updated
December 24, 2013
Sponsor
Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01504724
Brief Title
Effect of the Adjunctive IVB Before PRP
Acronym
IVB
Official Title
Effect of Adjunctive Intravitreal Bevacizumab Before Panretinal Photocoagulation in Macular Thickness and Retinal Nerve Fiber Layer Thickness
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
central macular thickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVB group
Arm Type
Experimental
Arm Description
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.
Arm Title
only PRP group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
Avastin; Genentech, Inc., South San Francisco, CA, USA
Intervention Description
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
Primary Outcome Measure Information:
Title
Central macular thickness
Description
central macular thickness measured by Cirrus HD optical coherence tomography
Time Frame
6 months after first PRP session
Secondary Outcome Measure Information:
Title
Retinal nerve fiber layer thickness
Description
retinal nerve fiber layer thickness measured by Cirrus HD optical coherence tomography.
Time Frame
6 months after first PRP session

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Ho Park, M.D.
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dong Ho Park
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21705686
Citation
Jo YJ, Heo DW, Shin YI, Kim JY. Diurnal variation of retina thickness measured with time domain and spectral domain optical coherence tomography in healthy subjects. Invest Ophthalmol Vis Sci. 2011 Aug 17;52(9):6497-500. doi: 10.1167/iovs.11-7403.
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Effect of the Adjunctive IVB Before PRP

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