Efficacy of Fixed Monthly Dosing of Ranibizumab in Neovascular Age-related Macular Degeneration (NCT02944227) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Fixed Monthly Dosing of Ranibizumab in Neovascular Age-related Macular Degeneration
South Korea20 participantsStarted 2016-03-03
Plain-language summary
The objective of this pilot study is to evaluate the efficacy of intensive fixed monthly dosing of intravitreal Lucentis® (Ranibizumab) for the treatment of SRF and PED in neovascular AMD which is persistent to anti-VEGF (anti-vascular endothelial growth factor) monotherapy.
Who can participate
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
. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
. Age equal to or older than 50 years.
. Presence of SRF associated with PED in neovascular AMD (proven with OCT FA, and ICG) which is persistent despite consecutive anti-VEGF injections for at least 9 months (3 initial loading doses with 4 week interval followed by PRN regimen)
Exclusion criteria
. Administration of periocular, intravitreal, or systemic corticosteroid within 3 months prior to visit 1 in the study eye
. Prior treatment with photodynamic therapy in the study eye
. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
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.