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

Branch Retinal Vein Occlusion Clinical Trial

Official title:

A Randomized Trial Comparing Intravitreal Ranibizumab and Macular Laser Photocoagulation for the Treatment of Macular Edema Following Branch Retinal Vein Occlusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01189526
• Other study ID #: RVOIVRI
• Secondary ID: BRVOIVRI
• Status: Recruiting
• Phase: Phase 3
• First received: August 25, 2010
• Last updated: August 25, 2010
• Start date: January 2009
• Est. completion date: August 2011

Study information

• Verified date: August 2010
• Source: Seoul Retina Investigator Group
• Contact: Song Ee Chung, M.D.
• Email: songee129[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

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

Procedure:
• macular laser photocoagulation
Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul Retina Investigator Group	Kyungpook National University, Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity (ETDRS letters)		48 weeks	No
Secondary	Retinal Thickening	Optical Coherence Tomography measured central retinal thickness	48 weeks	No