Aflibercept Injection for Proliferative Diabetic Retinopathy
United States12 participantsStarted 2013-03
Plain-language summary
To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.
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:
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years
* Diagnosed with proliferative diabetic retinopathy (PDR) requiring pars plana vitrectomy (PPV)
* Best corrected visual acuity in the study eye between 20/40 to light perception (LP) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart
Exclusion Criteria:
* Pregnancy (positive urine pregnancy test) or lactation
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.
* Participation in a study of an investigational drug or device within the past 30 days prior to enrolling in the study
* For previously treated subjects -
* Prior treatment with anti-vascular endothelial growth factor (anti-VEGF) therapy in the study eye within 28 days of Screening
* Prior treatment with triamcinolone in the study eye within 6 months of Screening.
* Prior treatment with dexamethasone in the study eye within 30 days of Screening
* 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 PDR in the study eye
* Active intraocu…
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
Rate of Resolved Post-operative Vitreous Hemorrhage.