Analysis of Aqueous and Vitreous Humor (NCT02067013) | Clinical Trial Compass
UnknownPhase 2
Analysis of Aqueous and Vitreous Humor
United States45 participantsStarted 2015-07
Plain-language summary
Clinical Retina research studies often collect aqueous samples in hopes of estimating levels of drug or cytokines in the vitreous. Little is known about how well vitreous and aqueous correlate. This study will collect vitreous and aqueous samples at the same time to evaluate and compare drug and cytokine levels.
The overall objective of this study is to evaluate the molecular concentration of growth factors, cytokines and chemokines in human aqueous humor and vitreous samples collected from individuals undergoing pars plana vitrectomy for tractional retinal detachment secondary to proliferative diabetic retinopathy, exudative or tractional retinal detachment secondary to macular degeneration, macular hole or neovascular glaucoma.
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
* Subjects with a diagnosis of tractional retinal detachment secondary to proliferative diabetic retinopathy, age-related macular degeneration with tractional or exudative retinal detachment, macular hole, epiretinal membrane, or neovascular glaucoma.
Exclusion Criteria:
* Subjects with history of vitrectomy in the study eye
* Presence of vitreous hemorrhage
* Subjects with history of laser photocoagulation in the study eye within 3 months of vitrectomy
* Subjects unwilling to undergo pars plana vitrectomy
* Subjects unwilling to receive intravitreal ranibizumab prior to pars plana vitrectomy unless diagnosis of macular hole or epiretinal membrane
* Subjects who may need or have received systemic anti-VEGF for oncology in the past year
* Subjects with history of anti-VEGF injection within 4 months before vitrectomy
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.