CompletedPhase 3

Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion

Japan47 participantsStarted 2011-06

Plain-language summary

The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.

Who can participate

Age range

18 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: * Japanese patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Diagnosis within 12 months prior to Visit 1 * Best-corrected visual acuity (BCVA): * CRVO: BCVA score ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2 * BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2 Exclusion Criteria: * Pregnant or nursing women * History of stroke * Uncontrolled blood pressure * Active ocular infection or intraocular inflammation in either eye * Uncontrolled glaucoma in either eye * Neovascularization of the iris or neovascular glaucoma in either eye * Prior episode of RVO more than 12 months prior to Visit 1 in the study eye * Use of any systemic anti-VEGF drugs within 6 months prior to Visit 2 * Prior treatment with any anti-angiogenic drugs within 3 months prior to Visit 2 in either eye * Prior panretinal laser photocoagulation within 3 months prior to Visit 2 in the study eye * Prior focal/grid laser photocoagulation within 4 months prior to Visit 2 in the study eye * Use of intra-/peri-ocular corticosteroids within 3 months prior to Visit 1 in the study eye * Use of any intra-ocular corticosteroid implants in the study eye Other protocol-defined inclusion/exclusion criteria may apply

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

Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline

Timeframe: 3 months

Trial details

NCT IDNCT01377597

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-04

View on ClinicalTrials.gov More Retinal Vein Occlusion trials