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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Seoul Retina Investigator Group.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Samsung Medical Center
Kyungpook National University
Information provided by:
Seoul Retina Investigator Group
ClinicalTrials.gov Identifier:
NCT01189526
First received: August 25, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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

Condition Intervention Phase
Branch Retinal Vein Occlusion
Drug: Ranibizumab
Procedure: macular laser photocoagulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Intravitreal Ranibizumab and Macular Laser Photocoagulation for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion

Resource links provided by NLM:


Further study details as provided by Seoul Retina Investigator Group:

Primary Outcome Measures:
  • Best Corrected Visual Acuity (ETDRS letters) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retinal Thickening [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Optical Coherence Tomography measured central retinal thickness


Estimated Enrollment: 60
Study Start Date: January 2009
Estimated Study Completion Date: August 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189526

Contacts
Contact: Song Ee Chung, M.D. songee129@hanmail.net
Contact: Yun Taek Kim, M.D. jjongofhim@naver.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Song Ee Chung, M.D.       songee129@hanmail.net   
Sub-Investigator: Song Ee Chung, M.D.         
Sub-Investigator: Yun Taek Kim, M.D.         
Sponsors and Collaborators
Seoul Retina Investigator Group
Samsung Medical Center
Kyungpook National University
Investigators
Principal Investigator: Se Woong Kang, M.D. Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Principal Investigator: Jae Pil Shin, M.D. Department of Ophthalmology, Kyungpook National University
  More Information

No publications provided

Responsible Party: Se Woong Kan, M.D. and Jae Pil Shin, M.D., Samsung Medical Center and Kyungpook National University
ClinicalTrials.gov Identifier: NCT01189526     History of Changes
Other Study ID Numbers: RVOIVRI, BRVOIVRI
Study First Received: August 25, 2010
Last Updated: August 25, 2010
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by Seoul Retina Investigator Group:
Branch retinal vein occlusion
macular edema
intravitreal injection
ranibizumab

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014