Ozurdex in Reducing PVR After Vitreotomy in PDR (NCT05415826) | Clinical Trial Compass
UnknownNot Applicable
Ozurdex in Reducing PVR After Vitreotomy in PDR
30 participantsStarted 2022-06-15
Plain-language summary
Diabetic retinopathy is a significant source of visual morbidity in the adult population. Complications of diabetic retinopathy include ischemic maculopathy, macular edema, and sequelae of fibrovascular proliferation, such as vitreous hemorrhage (VH), tractional retinal detachment (TRD), and neovascular glaucoma.Pars plana vitrectomy (PPV) is traditionally performed for nonclearing VH, significant fibrovascular proliferation, refractive macular edema, and/or TRD, particularly if macula-involving. However, the pathogenesis is complex and multifactorial: Pro-infammatory cytokines and chemokines signifcantly contribute to the disease development and promote ischemic changes in the retina. Therefore, there is a potential role for intravitreal steroids in disease modifcation.
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:
* macula off treatment naive TRD second to PDR causing visual loss;
* treated by standardize PPV, endolaser and silicone oil tamponade with or without DEX implant at the end of the surgery within 12 months from diagnosis of TRD;
* Hba1c is less than 10% with type 1 or 2 diabetes mellitus
Exclusion Criteria:
* other concomitant ocular diseases that cause RD ( for example rhegmatogenous retinal detachment, exudative retinal detachment, other causes for TRD);
* any previous injection of DEX implant;
* abnormalities of the vitreoretinal interface, such as epiretinal membrane, vitreomacular traction without RD
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
PVR
Timeframe: during 3 months after surgery
2
CRT
Timeframe: from preoperation to 3 months follow-up