The Effect of IVA for Preventing Postvitrectomy Hemorrhage in PDR (NCT05478967) | Clinical Trial Compass
CompletedNot Applicable
The Effect of IVA for Preventing Postvitrectomy Hemorrhage in PDR
China154 participantsStarted 2019-08-08
Plain-language summary
Aflibercept, a recombinant fusion antibody that binds to all subtypes of VEGF and PlGF, has been shown to induce effective regression of retinal neovascularization secondary to PDR but there had been lack of a well-structured prospective study about adjunctive use of intravitreal injection of Aflibercept (IVA) to reduce postoperative VH in PPV for PDR. In this study, we aim to assess the effect of preoperative IVA on the incidence of postoperative VH after PPV for PDR.
Who can participate
Age range
35 Years – 65 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:
* type 2 diabetes mellitus
* age between 35 and 65
* PDR who underwent primary pars plana vitrectomy for VH.
Exclusion Criteria:
* eyes with retinal tear
* eyes with iris or anterior angle neovascularization
* eyes with intraoperative use of silicone oil
* eyes with choroidal or retinal disease other than PDR or any inflammation condition
* eyes underwent any previous vitrectomy or scleral buckle surgery
* eyes received intraocular TA injection within 90 days before screening
* eyes received intraocular anti VEGF treatment within 60 days before screening or contralateral eyes received intraocular anti VEGF treatment during follow-up
* patients who had taken aspirin orally within 7 days before screening
* patient has coagulation mechanism disorder or other medicine for anticoagulant treatment
* cerebrovascular accident and / or myocardial infarction occurred within 180 days before screening
* patients with uncontrolled blood pressure (sitting position \> 160 / 100 mmHg)
* patients with liver or kidney dysfunction or any severe systemic disease.
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.