Clinical Study on Prognosis of Patients With Severe NPDR Undergoing Vitrectomy (NCT05852132) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study on Prognosis of Patients With Severe NPDR Undergoing Vitrectomy
China249 participantsStarted 2024-05-05
Plain-language summary
To investigate the prognosis of retinal structure and function after vitrectomy in patients with severe non-proliferative diabetic retinopathy, to explore the feasibility of vitrectomy in patients with severe non-proliferative diabetic retinopathy(NPDR), and to seek the best way to delay the progression of diabetic retinopathy from the perspective of therapeutic effect.
Who can participate
Age range
18 Years – 90 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
. Aged ≥18 years, men or women
. Severe nonproliferative diabetic retinopathy was diagnosed with any one of the following, according to the International Classification of Clinical Severity of Diabetic Retinopathy: more than 20 intraretinal hemorrhaged spots in any one of four quadrants, definite venous beading in more than two quadrants, or definite intraretinal microvascular changes in more than one quadrant.
. ETDRS beat corrected visual acuity(BCVA) letter score between 19 and 78 (Snellen equivalent 20/400-20/32) on the day of randomisation.
. At least partial corneal transparency (or central corneal transparency), good pupil dilation and full cooperation with PRP, and ensure that the fundus examination, visual function examination and optical coherence tomography (OCT) examination can be performed after vitrectomy.
. Able and willing to sign informed consent
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
1
Incidence of proliferative diabetic retinopathy (PDR)
. Unwilling or unable to provide consent for participation in the study, unwilling to submit to the randomisation process or unable to return for the scheduled protocol visits
. Participating in another clinical trial within the past 3 months.
. Previous intraocular laser therapy, intraocular surgery (excluding cataract surgery), or scheduled to undergo surgery within the next 6 months
. Previous poorly controlled glaucoma (defined as intraocular pressure ≥25mmHg after anti-glaucoma medication)
. Patients previously diagnosed with wet AMD, retinal vein occlusion and other neovascular retinopathy
. Patients previously diagnosed with macular membrane, ischemic optic neuropathy, uveitis and other definite fundus diseases.
. Received pro-VEGF or anti-VEGF treatment within the past 3 months (systemic or intravitreal).
. Has a history of corticosteroid treatment (peribulbar or intravitreal) in the past 3 months