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

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ClinicalTrials.gov Identifier: NCT01189526
Recruitment Status : Unknown
Verified August 2010 by Seoul Retina Investigator Group.
Recruitment status was:  Recruiting
First Posted : August 26, 2010
Last Update Posted : August 26, 2010
Sponsor:
Collaborators:
Samsung Medical Center
Kyungpook National University Hospital
Information provided by:
Seoul Retina Investigator Group

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

  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 or disease Intervention/treatment Phase
Branch Retinal Vein Occlusion Drug: Ranibizumab Procedure: macular laser photocoagulation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2009
Actual Primary Completion Date : August 2010
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

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.




Primary Outcome Measures :
  1. Best Corrected Visual Acuity (ETDRS letters) [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Retinal Thickening [ Time Frame: 48 weeks ]
    Optical Coherence Tomography measured central retinal thickness



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189526


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

Locations
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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 Hospital
Investigators
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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

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Responsible Party: Se Woong Kan, M.D. and Jae Pil Shin, M.D., Samsung Medical Center and Kyungpook National University
ClinicalTrials.gov Identifier: NCT01189526    
Other Study ID Numbers: RVOIVRI
BRVOIVRI
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: August 26, 2010
Last Verified: August 2010
Keywords provided by Seoul Retina Investigator Group:
Branch retinal vein occlusion
macular edema
intravitreal injection
ranibizumab
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents