Pars-plana Vitrectomy vs Panretinal Photocoagulation for Severe NPDR (NCT04103671) | Clinical Trial Compass
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Pars-plana Vitrectomy vs Panretinal Photocoagulation for Severe NPDR
China272 participantsStarted 2019-12-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Aged ≥18 years, male or female
✓. Type 1 or type 2 diabetes
✓. Presence of severe NPDR according to the diagnosis of 4-2-1 rule,
✓. Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity letter score \> 24 (approximate Snellen equivalent 20/320) on the day of randomization.
✓. Media clarity, pupillary dilation, and study participant cooperation sufficient to administer PRP and obtain adequate fundus photographs and optical coherence tomography (OCT).
✓. Able and willing to provide informed consent
Exclusion criteria
✕. Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
✕. In the opinion of the investigator, A condition that would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
✕
What they're measuring
1
progression rate of severe non proliferative diabetic retinopathy
Timeframe: 12 months
Trial details
NCT IDNCT04103671
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied.