UnknownPhase 3

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

South Korea60 participantsStarted 2009-01

Plain-language 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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Best Corrected Visual Acuity (ETDRS letters)

Timeframe: 48 weeks

Trial details

NCT IDNCT01189526

SponsorSeoul Retina Investigator Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2010-08

Contact for this trial

Song Ee Chung, M.D.

songee129@hanmail.net

View on ClinicalTrials.gov More Branch Retinal Vein Occlusion trials