Intravitreal Aflibercept Injection for Radiation Retinopathy Trial
United States40 participantsStarted 2017-07-05
Plain-language summary
The ARRT trial will assess the safety and efficacy of 2mg aflibercept for the treatment of radiation retinopathy, including maculopathy and optic neuropathy over 52 weeks.
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
. Age \> 18 years of age
. Clinically identifiable radiation retinopathy with evidence of fluid on SD-OCT causing vision loss in the study eye
. Undergone either ocular or orbital radiation for any primary ocular or orbital cancer within clinical evidence of having radiation retinopathy
. Willing and able to comply with clinic visits and study-related procedures
. Provide signed informed consent
Exclusion criteria
. Metastatic cancer or any active primary cancer, at time of enrollment
. Prior treatment with anti VEGF in the study within 60 days of screen in the study eye
. Prior intravitreal or subconjunctival treatment with cortical steroids within 90 days of screen in the study eye
. Macular ischemia (defined as greater than 5 disc areas), as assessed by the investigator
. Media opacity obscuring a view of the fundus or any other reason for vision loss other than radiation retinopathy.
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
1
Safety of intravitreal Aflibercept for the treatment of radiation retinopathy - Assessed by incidence of adverse events.
. Evidence of infectious ocular infection, in the study eye, at time of screening
. Pregnant or breast-feeding women
. Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception start of the first treatment, during the study, and for at least 3 months after the last dose. Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly.