RecruitingNot Applicable

Early Vitrectomy vs PRP in Early Proliferative Diabetic Retinopathy

China100 participantsStarted 2025-01-01

Plain-language summary

The goal of this clinical trial is to learn whether early microincision vitrectomy surgery (MIVS) can improve retinal neovascularization outcomes compared to standard pan-retinal photocoagulation (PRP) in patients with early proliferative diabetic retinopathy (PDR). It will also evaluate the safety and functional outcomes of early surgical intervention in this population. The main questions it aims to answer are: Does early MIVS increase the proportion of eyes achieving complete regression of retinal neovascularization at 12 months? Does early MIVS improve visual and functional outcomes, including visual acuity and visual field, compared to PRP? Researchers will compare early MIVS combined with peripheral scatter photocoagulation to standard PRP to determine whether early surgical intervention leads to better regression of neovascularization and improved clinical outcomes. Participants will: Receive either MIVS with peripheral photocoagulation or standard PRP Undergo retinal imaging assessments including fundus fluorescein angiography (FFA) or optical coherence tomography angiography (OCTA) Complete follow-up visits over 12 months, including visual acuity testing, visual field testing, and optical coherence tomography (OCT) imaging Be monitored for the occurrence of vitreous hemorrhage and other clinical outcomes

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: * Age 18 years or older. Diagnosis of type 2 diabetes mellitus. Presence of early proliferative diabetic retinopathy with active neovascularization, or mild vitreous hemorrhage or preretinal hemorrhage that does not interfere with evaluation of neovascularization. Relatively clear optical media, good pupillary dilation, and sufficient cooperation for panretinal photocoagulation and retinal imaging. Ability and willingness to provide written informed consent. If both eyes are eligible, the eye with worse vision will be included. Exclusion Criteria: * Prior panretinal photocoagulation, macular photocoagulation, or vitrectomy in the study eye. Retinal traction or retinal detachment. Optic neuropathy. Macular edema caused by reasons other than diabetes. Coexisting ocular disease that may decrease visual acuity during the study. Substantial cataract likely to decrease visual acuity by more than three lines. Major ocular surgery within the past 4 months or planned intraocular surgery within the next 6 months. YAG capsulotomy within the past 2 months. Any intravitreal injection within the past 3 months. Aphakia. Severe external ocular infection. Uncontrolled glaucoma. Significant renal disease requiring dialysis or kidney transplantation. Unstable glycemic control. Blood pressure greater than 180/110 mmHg. History of transient ischemic attack, stroke, myocardial infarction, acute congestive heart failure, or other acute cardiac event requir…

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

Proportion of Eyes With Complete Regression of Neovascularization

Timeframe: 12 months

Trial details

NCT IDNCT07586787

SponsorXiamen Ophthalmology Center Affiliated to Xiamen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-10

Contact for this trial

xiuju Chen, md

+8618060955810 joyychen@aliyun.com

View on ClinicalTrials.gov More Proliferative Diabetic Retinopathy (PDR) trials