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

Sponsor

Seoul Retina Investigator Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT01189526

Collaborator

Samsung Medical Center (Other), Kyungpook National University Hospital (Other)

Enrollment

Location

Arms

30.9

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Branch Retinal Vein Occlusion	Drug: Ranibizumab Procedure: macular laser photocoagulation	Phase 3

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2009

Actual Primary Completion Date :

Aug 1, 2010

Anticipated Study Completion Date :

Aug 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Best Corrected Visual Acuity (ETDRS letters) [48 weeks]

Secondary Outcome Measures

Retinal Thickening [48 weeks]
Optical Coherence Tomography measured central retinal thickness

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

Seoul Retina Investigator Group
Samsung Medical Center
Kyungpook National University Hospital

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