Age-Related Macular Degeneration (ARMD) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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,

• One or more of the following, in the absence of PDR:

⁃ More than 20 intraretinal hemorrhages in each of four quadrants

⁃ Definite venous beading in two or more quadrants

⁃ Prominent intraretinal microvascular abnormality (IRMA) in one or more quadrants

• 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

Locations
Other Locations
China
Zhongshan Ophthalmic Center
RECRUITING
Guangzhou
Contact Information
Primary
tao li, Dr
litao2@mail.sysu.edu.cn
66683995
Backup
shida chen, Dr
chenshd3@mail.sysu.edu.cn
66610721
Time Frame
Start Date: 2019-12-04
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 272
Treatments
Experimental: Group A
Prompt panretinal photocoagulation
Experimental: Group B
Micro-invasive Pars-plana vitrectomy
Related Therapeutic Areas
Diabetic Retinopathy
Late-Onset Retinal Degeneration
Vitrectomy
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: Zhongshan Ophthalmic Center, Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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