NCT04103671

Pars-plana Vitrectomy vs Panretinal Photocoagulation for Severe NPDR

Micro-invasive Pars-plana Vitrectomy vs Panretinal Photocoagulation for Severe Non-Proliferative Diabetic Retinopathy A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is estimated that there are about 600 million diabetes mellitus (DM) patients all over the world until 2040，and almost 50% of whom have some degree of diabetic retinopathy (DR) at any given time. About 5% to 10% diabetic retinopathy would develop vision-threatening complications, including proliferative diabetic retinopathy (PDR), capillary non-perfusion, or macular edema. Data from the DRS suggest that given long enough duration of diabetes, approximately 60% of patients with DR will develop PDR, and without intervention, 75% nonproliferative diabetic retinopathy (NPDR) will development PDR within 1 year follow up, 45% will develop high-risk PDR, nearly half of PDR will experience profound visual loss. panretinal photocoagulation (PRP) only reduced 50% risk of sever visual loss and about 25% of the sNPDR patients who finished PRP need Pars-plana vitrectomy (PPV) in a 5 year follow up. Vitreous have been proven to play an important role in the development of NPDR to PDR, which were the collection of vascular endothelial growth factor (VEGF) factors and the major component of proliferative lesion in the later stage of PDR. Micro-invasive Pars-plana vitrectomy has been shown as a safe and effective method in the treatment of PDR, through removing the pathological vitreous, proliferative membrane and also the VEGF factors. However, whether or not Micro-invasive Pars-plana vitrectomy will be more effective than PRP to control the progression of NDPR remained unknown.

Conditions

• Non Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
PROCEDURE	Prompt panretinal photocoagulation	Study eyes that receive panretinal photocoagulation (prompt PRP eyes at baseline) should have 1200 to1600 burns with a spot size on the retina of approximately 500 microns given over 1 to 3 sittings and completed within 4 weeks of initiation
PROCEDURE	25G Pars-plana vitrectomy	Study eyes that receive standard 25G Pars-plana vitrectomy that remove all the vitreous, without laser or Silicone oil tamponade, but filled with perfusion fluid. Surgery should be completed within 4 weeks after randomization.

Timeline

• Start date: 2019-12-04
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2019-09-25
• Last updated: 2023-03-30

Locations

1 site across 1 country: China