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

August 25, 2010 updated by: Seoul Retina Investigator Group

A Randomized Trial Comparing Intravitreal Ranibizumab and Macular Laser Photocoagulation for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion

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

  1. Multicenter, randomized clinical trial. (intravitreal Ranibizumab 0.5mg injection vs. macular laser photocoagulation)
  2. After 48 weeks follow up, functional change(visual acuity)and anatomical change (central retinal thickness) would be evaluated

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Sub-Investigator:
          • Song Ee Chung, M.D.
        • Sub-Investigator:
          • Yun Taek Kim, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IVRI
IVRI : intravitreal ranibizumab (0.5mg) injection
Drug: Ranibizumab
Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.
Active Comparator: Laser
Laser : macular laser photocoagulation
Procedure: macular laser photocoagulation
Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best Corrected Visual Acuity (ETDRS letters)
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal Thickening
Time Frame: 48 weeks
Optical Coherence Tomography measured central retinal thickness
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul Retina Investigator Group

Collaborators

Samsung Medical Center
Kyungpook National University Hospital

Investigators

  • Principal Investigator: Jae Pil Shin, M.D., Department of Ophthalmology, Kyungpook National University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

August 25, 2010

First Posted (Estimate)

August 26, 2010

Study Record Updates

Last Update Posted (Estimate)

August 26, 2010

Last Update Submitted That Met QC Criteria

August 25, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVOIVRI
  • BRVOIVRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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