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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01189526

Enrollment

Registered

2010-08-26

Start date

2009-01-31

Completion date

2011-08-31

Last updated

2010-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Branch Retinal Vein Occlusion

Keywords

Branch retinal vein occlusion, macular edema, intravitreal injection, ranibizumab

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

Interventions

DRUGRanibizumab

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

PROCEDUREmacular laser photocoagulation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Best Corrected Visual Acuity (ETDRS letters)	48 weeks

Secondary

Measure	Time frame	Description
Retinal Thickening	48 weeks	Optical Coherence Tomography measured central retinal thickness

Countries

South Korea

Contacts

Primary ContactSong Ee Chung, M.D.

songee129@hanmail.net

Backup ContactYun Taek Kim, M.D.

jjongofhim@naver.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026