Intense Treatment Regimen With Intravitreal Aflibercept Injection
United States30 participantsStarted 2018-09-11
Plain-language summary
This study will evaluate the safety and efficacy of intense dosing for a limited period in patients who demonstrate refractory disease on monthly IAI. Patients will be followed for 52 weeks
Who can participate
Age range
50 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 ≥ 50 years
* Choroidal neovascularization related to age-related macular degeneration
* Prior treatment with any anti-VEGF agent for ≥ 12 months
* Prior treatment with at least five consecutive IAI at baseline with an average treatment interval of maximum 35 days
* Presence of foveal fluid at most recent clinical visit occurring 30 (+/- 5) days following the most recent IAI
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
* Monocular patients
* Patients with a previous history of macular thermal laser or PDT
* Confounding ocular conditions in the study eye that may affect interpretation of OCT, BCVA or assessment of macular appearance (eg. cataract, epiretinal membrane, retinal vascular occlusive disease)
* Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
* Active intraocular inflammation (grade trace or above) in the study eye
* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
* Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
* History of cerebral vascular accident, myocardial infarction, transient ischemic attacks wi…
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
Incidence and severity of ocular and non ocular adverse events through to week 12 of intensive IAI therapy
Timeframe: Baseline to 12 weeks
Trial details
NCT IDNCT03594461
SponsorVitreous -Retina- Macula Consultants of New York