Proliferative Diabetic Retinopathy Clinical Trial
Official title:
Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy
Verified date | February 2021 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Panretinal photocoagulation (PRP) has been the standard treatment for Proliferative diabetic retinopathy (PDR) since the Diabetic Retinopathy Study demonstrated its benefit nearly 40 years ago,but PRP has inevitable adverse effects on visual function. Intravitreal injection of vascular endothelial growth factor(VEGF) can induce short-term regression of retinal neovascularization(NV). The purpose is to assess and compare the efficacy and safety between intravitreal injection of conbercept and PRP.
Status | Enrolling by invitation |
Enrollment | 226 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Participants of either sex aged 18 years or over. 2. Diagnosis of diabetes mellitus (type 1 or 2). 3. Best-corrected visual acuity (BCVA) in the study eye better than or equal to 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters 4. PDR with no evidence of previous PRP. 5. Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs. Exclusion Criteria: 1. a glycated haemoglobin (HbA1c) level of more than 10%; 2. Blood pressure > 180/100 mmHg 3. Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months 4. dialysis or renal transplant 5. Systemic anti-VEGF or pro-VEGF treatment within 6 months prior to randomization 6. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years 7. Traction retinal detachment involving the macula 8. Exam evidence of neovascularization of the angle 9. History of major ocular surgery or anticipated within the next 6 months following randomization |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Writing Committee for the Diabetic Retinopathy Clinical Research Network, Gross JG, Glassman AR, Jampol LM, Inusah S, Aiello LP, Antoszyk AN, Baker CW, Berger BB, Bressler NM, Browning D, Elman MJ, Ferris FL 3rd, Friedman SM, Marcus DM, Melia M, Stockdale CR, Sun JK, Beck RW. Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial. JAMA. 2015 Nov 24;314(20):2137-2146. doi: 10.1001/jama.2015.15217. Erratum in: JAMA. 2016 Mar 1;315(9):944. JAMA. 2019 Mar 12;321(10):1008. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome is mean visual acuity change(BCVA) | Primary outcome is the change in BCVA from screening to 12 moths in the study eye measured in the ETDRS letter score at 4 m | 12 months | |
Secondary | Visual acuity outcomes in terms of visual gain or loss | visual gain refers to the proportion of visual improvement = 15 letters at 6-month follow-up, visual loss refers to the proportion of visual reduction = 15 letters at 6-month and 12-month follow-up | 6 months and 12 months | |
Secondary | the regression patterns of new vessels | the complete regression proportion of new retinal vessels is evaluated by the fundus photography and fundus fluorescein angiography at 6 months and 12 months | 6 months and 12 months | |
Secondary | proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy | proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy at months | 12 months | |
Secondary | change of visual field | change of visual field will be evaluated by the perimeter | 12 months | |
Secondary | change of retinal function | change of retinal function measured by electroretinography(ERG) | 12 months | |
Secondary | change of macular capillary density | change of macular capillary density measured by Optical coherence tomography angiography | 12 months | |
Secondary | change of central retinal thickness | change of central retinal thickness measured by Optical coherence tomography | 12 months |
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