Study to Gather Information on the Safety and Use of Aflibercept Injections Into the Eye for the … (NCT04137120) | Clinical Trial Compass
CompletedNot Applicable
Study to Gather Information on the Safety and Use of Aflibercept Injections Into the Eye for the Treatment of Eye Disorders in Mexican Routine Clinical Practice
Mexico73 participantsStarted 2021-02-19
Plain-language summary
The study aims to collect data on the safety and use of intravitreal aflibercept injections into the eye for the treatment of eye disorders that cause blurred vision or a blind spot due to abnormal or blocked blood vessels. Data will be collected from patients who are being treated for such eye disorders in Mexican routine clinical practice.
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:
* Adult patients with a diagnosis of a wet age-related macular degeneration (wAMD), diffuse diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO), macular edema secondary to branch retinal vein occlusion (BRVO) or myopic choroidal neovascularization (mCNV);
* Decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice and independently of study inclusion;
* Treatment naïve or pre-treated for macular diseases (to anti-VEGF and steroid intravitreal treatments); patients who underwent laser photocoagulation and/or are being treated with panretinal photocoagulation therapies are eligible for study participation;
* If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept
Exclusion Criteria:
* Patient diagnosed with two or more of the studied indications in the same eye (wAMD, DME, CRVO, BRVO and mCNV);
* Patients that were already treated with anti-VEGF or steroids are allowed to be enrolled only if they received the last dose of anti-VEGF 3 or more months ago and in the case of a steroid implant 6 months after the last dose;
* Current treatment with other intravitreal therapies
* Contra-indications according to Eylea's / Wetlia's local marketing authorization:
* Ocular or periocular infection
* Active intraocular Inflammation
* Known hyper…
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.
1Since this study has already been completed and was focused specifically on tracking safety problems — both in the eye and in the rest of the body — with aflibercept injections in Mexican patients, can you tell me what the results showed about the most common or serious side effects that were reported?
2This trial was an observational study in routine clinical practice rather than a controlled experiment, so how does that affect how confident we can be about what the safety data tells us about aflibercept for my specific type of retinal disease?
3The study tracked what happened after adverse events occurred — including whether the drug was stopped or changed — so based on findings like these, what is your plan if I experience a serious eye-related side effect during treatment with aflibercept?
4Because this study was done in a real-world clinical setting rather than a tightly controlled trial, do you think the safety profile it captured reflects what I might experience, and are there any differences in my situation that might make my risk higher or lower than what was observed?
5Are there alternative treatments for my retinal condition that we should compare against aflibercept, especially given that this study was primarily measuring safety rather than how well the treatment works?
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.