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

NCT ID: NCT01189526

Last Updated: 2010-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Branch Retinal Vein Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IVRI

IVRI : intravitreal ranibizumab (0.5mg) injection

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.

Laser

Laser : macular laser photocoagulation

Group Type ACTIVE_COMPARATOR

macular laser photocoagulation

Intervention Type PROCEDURE

Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.

Interventions

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Ranibizumab

Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.

Intervention Type DRUG

macular laser photocoagulation

Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role collaborator

Seoul Retina Investigator Group

NETWORK

Sponsor Role lead

Responsible Party

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Samsung Medical Center and Kyungpook National University

Principal Investigators

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Se Woong Kang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Jae Pil Shin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Kyungpook National University

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Song Ee Chung, M.D.

Role: CONTACT

Yun Taek Kim, M.D.

Role: CONTACT

Facility Contacts

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Song Ee Chung, M.D.

Role: primary

Other Identifiers

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BRVOIVRI

Identifier Type: -

Identifier Source: secondary_id

RVOIVRI

Identifier Type: -

Identifier Source: org_study_id

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