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

Seoul Retina Investigator Group

Status and phase: Unknown; Phase 3

Conditions: Branch Retinal Vein Occlusion

Treatments: Procedure: macular laser photocoagulation; Drug: Ranibizumab

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01189526

RVOIVRI

BRVOIVRI

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

IVRI

Experimental group

Description:

IVRI : intravitreal ranibizumab (0.5mg) injection

Treatment:

Drug: Ranibizumab

Laser

Active Comparator group

Description:

Laser : macular laser photocoagulation

Treatment:

Procedure: macular laser photocoagulation