UnknownPhase 2

Intravitreal Aflibercept for the Prevention of Proliferative Vitreoretinopathy Following Retinal Detachment Repair

United States150 participantsStarted 2020-10-15

Plain-language summary

The primary objective of the study is to determine if serial intravitreal aflibercept injections (IAI) improve the single surgery anatomic success rate following surgical repair of primary, macula involving rhegmatogenous retinal detachment (RRD) deemed at high risk for proliferative vitreoretinopathy (PVR). Preclinical work has revealed that competitive inhibition of platelet derived growth factor (PDGF) by vascular endothelial growth factor (VEGF) potentiates a pathologic, sustained activation of PDGF receptors that is critical to the progression of experimental PVR. VEGF blockade would mitigate this pathologic activation.

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

. Carry a diagnosis of a macula involving ("macula off") primary RRD at high risk for PVR development. Specifically, the enrolled eye must include at least 1 but no more than 3 high risk features, which are designated as follows: multiple retinal breaks (\>3); detachments involving two or more quadrants of the retina; duration of detachment \> 3 weeks; vitreous hemorrhage; and choroidal detachment.
. Consent to surgical repair utilizing pars plana vitrectomy with or without scleral buckling and C3F8 gas tamponade
. Willing and able to comply with clinic visits and study-related procedures
. Provide signed informed consent
. Able to understand and complete study-related questionnaires

Exclusion criteria

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

Single surgery anatomic success (retinal re-attachment) rate

Timeframe: 4 months

Trial details

NCT IDNCT04580147

SponsorM. Ali Khan, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-15

Contact for this trial

Brianna Kenney

215-928-3092 research@midatlanticretina.com

View on ClinicalTrials.gov More Retinal Detachment With Multiple Breaks, Unspecified Eye trials