Early vitrectomy with PRP for early proliferative diabetic retinopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares two approaches for early proliferative diabetic retinopathy: microincision vitrectomy surgery plus peripheral photocoagulation versus standard panretinal photocoagulation alone. It aims to see if early surgery can achieve higher rates of complete neovascular regression at 12 months and better visual and functional outcomes, such as visual acuity and visual field. Safety and functional effects of early surgical intervention will also be evaluated. Participants will be adults with type 2 diabetes and early PDR with active neovascularization or mild hemorrhage, randomized to one of the two treatments and followed with retinal imaging. The study hypothesizes that removing the vitreous scaffold and reducing VEGF may enhance disease control compared with conventional PRP alone.

Why it matters

Who can join: the full rules

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 requiring hospitalization within the past 4 months.

Pregnant, lactating, or intending to become pregnant during the study period.

Participation in another clinical trial.

Unwilling or unable to provide informed consent, undergo randomization, or return for scheduled visits.

Where it's running

• Xiamen Eye Center of Xiamen University
  Xiamen, Fujian, China Recruiting
• Peking University People's Hospital
  Beijing, Beijing Municipality, China Completed
• Henan Province People's Hospital
  Zhengzhou, Henan, China Completed
• Jiangsu Provincial People's Hospital
  Nanjing, Jiangsu, China Completed
• Nanjing Medical University affiliated Eye Hospital
  Nanjing, Jiangsu, China Completed
• The First Affiliated Hospital of Dalian Medical University
  Dalian, Liaoning, China Completed

Study contacts

• Principal investigator: Xiaoxin Li, PhD — Xiamen Eye Center of Xiamen University
• Study coordinator: xiuju Chen, md
• Email: joyychen@aliyun.com
• Phone: +8618060955810

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Feasibility of trained non-medical professionals performing laser treatment for PDR and impact on service delivery

  This study tests whether trained eye care professionals can safely perform laser treatment for proliferative diabetic retinopathy and whether using them could increase clinic capacity.

  Recruiting Swansea Bay University Health Board · Swansea · NCT07923292

• Faricimab plus PRP versus vitrectomy with endolaser for proliferative diabetic retinopathy

  This trial will test whether faricimab plus panretinal photocoagulation (PRP) or vitrectomy with endolaser gives better long-term vision and fewer follow-up treatments for adults with proliferative diabetic retinopathy.

  Recruiting at 34 sites Phase 3 Jaeb Center for Health Research · Huntington Beach, California and 33 other locations · NCT06790784

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.