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Comparison of Intravitreal Ranibizumab and Macular Laser Photocoagulation for ME Following Branch Retinal Vein Occlusion (BRVO)

Primary Purpose

Branch Retinal Vein Occlusion

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ranibizumab
macular laser photocoagulation
Sponsored by
Seoul Retina Investigator Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Branch Retinal Vein Occlusion focused on measuring Branch retinal vein occlusion, macular edema, intravitreal injection, ranibizumab

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptom duration < 6 Months, > 4 weeks
  • Visual acuity - less than 20/40 (73 letters) more than 20/400 (19 letters) in ETDRS chart
  • OCT - center involved retinal thickening : > 250 micrometers
  • clear media
  • well controlled hypertension (<140/90mmHg) and diabetes (6.5<HbA1c<9.5)
  • willing to return for all scheduled visits

Exclusion Criteria:

  • uveitis,NVG, exudative AMD, diabetic retinopathy, Irvine-Gass syndrome, OIS
  • any malignancy
  • previous treatment history - laser photocoagulation, intravitreal injection with any drug, vitrectomy
  • vitreomacular traction or epiretinal membrane
  • intraocular surgery in the study eye within 6 months
  • uncontrolled glaucoma ( > 30mmHg with anti-glaucoma medications)
  • optic neuropathy, amblyopia
  • A condition that in the opinion of the investigator would preclude a patient's participation in the study

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IVRI

Laser

Arm Description

IVRI : intravitreal ranibizumab (0.5mg) injection

Laser : macular laser photocoagulation

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity (ETDRS letters)

Secondary Outcome Measures

Retinal Thickening
Optical Coherence Tomography measured central retinal thickness

Full Information

First Posted
August 25, 2010
Last Updated
August 25, 2010
Sponsor
Seoul Retina Investigator Group
Collaborators
Samsung Medical Center, Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01189526
Brief Title
Comparison of Intravitreal Ranibizumab and Macular Laser Photocoagulation for ME Following Branch Retinal Vein Occlusion (BRVO)
Official Title
A Randomized Trial Comparing Intravitreal Ranibizumab and Macular Laser Photocoagulation for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul Retina Investigator Group
Collaborators
Samsung Medical Center, Kyungpook National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed to evaluate the efficacy of intravitreal Ranibizumab in comparison with macular laser photocoagulation as treatments for macular edema secondary to branch retinal vein occlusion. Characteristics of this study is as below Multicenter, randomized clinical trial. (intravitreal Ranibizumab 0.5mg injection vs. macular laser photocoagulation) After 48 weeks follow up, functional change(visual acuity)and anatomical change (central retinal thickness) would be evaluated

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branch Retinal Vein Occlusion
Keywords
Branch retinal vein occlusion, macular edema, intravitreal injection, ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVRI
Arm Type
Experimental
Arm Description
IVRI : intravitreal ranibizumab (0.5mg) injection
Arm Title
Laser
Arm Type
Active Comparator
Arm Description
Laser : macular laser photocoagulation
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.
Intervention Type
Procedure
Intervention Name(s)
macular laser photocoagulation
Intervention Description
Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity (ETDRS letters)
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Retinal Thickening
Description
Optical Coherence Tomography measured central retinal thickness
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptom duration < 6 Months, > 4 weeks Visual acuity - less than 20/40 (73 letters) more than 20/400 (19 letters) in ETDRS chart OCT - center involved retinal thickening : > 250 micrometers clear media well controlled hypertension (<140/90mmHg) and diabetes (6.5<HbA1c<9.5) willing to return for all scheduled visits Exclusion Criteria: uveitis,NVG, exudative AMD, diabetic retinopathy, Irvine-Gass syndrome, OIS any malignancy previous treatment history - laser photocoagulation, intravitreal injection with any drug, vitrectomy vitreomacular traction or epiretinal membrane intraocular surgery in the study eye within 6 months uncontrolled glaucoma ( > 30mmHg with anti-glaucoma medications) optic neuropathy, amblyopia A condition that in the opinion of the investigator would preclude a patient's participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Song Ee Chung, M.D.
Email
songee129@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Taek Kim, M.D.
Email
jjongofhim@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, M.D.
Organizational Affiliation
Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Pil Shin, M.D.
Organizational Affiliation
Department of Ophthalmology, Kyungpook National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Ee Chung, M.D.
Email
songee129@hanmail.net
First Name & Middle Initial & Last Name & Degree
Song Ee Chung, M.D.
First Name & Middle Initial & Last Name & Degree
Yun Taek Kim, M.D.

12. IPD Sharing Statement

Learn more about this trial

Comparison of Intravitreal Ranibizumab and Macular Laser Photocoagulation for ME Following Branch Retinal Vein Occlusion (BRVO)

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