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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02911311
Other study ID # CONTINENT
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 12, 2019
Est. completion date December 2022

Study information

Verified date February 2021
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Proliferative diabetic retinopathy (PDR) is a leading cause of vision loss in patients with diabetes mellitus,which of the initial manifestation of PDR is retinal neovascularization at the disc or elsewhere.Panretinal photocoagulation (PRP) has been the standard treatment for PDR since the Diabetic Retinopathy Study demonstrated its benefit nearly 40 years ago,but PRP has inevitable adverse effects on visual function including peripheral visual field defects, night vision loss, loss of contrast sensitivity.Recent evidences have indicated that anti-vascular endothelial growth factor(VEGF) treatment can reduce the severity and delay the progression of DR.However,the impact of this treatment on visual function and the effect of anti-VEGF agents on retinal neovascularization compared with PRP remain unclear. It is possible that a long-acting anti-VEGF agent such as conbercept. So we design the study with is a prospective randomized controlled trial about Intravitreal injection of conbercept versus PRP on PDR.Primary outcome is the change in BCVA from screening to 12 months in the study eye measured in the ETDRS letter score at 4 m


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
intravitreal injection of conbercept
conbercept is an anti-VEGF agent and is approved by the Food and Drug Administration for wet age-related macular degeneration
Device:
PRP
panretinal photocoagulation (PPR) is the standard treatment for proliferative diabetic retinopathy (PDR) and is applied to the peripheral retinal tissue to ablate areas of the peripheral retina and thereby reduce retinal oxygen consumption

Locations

Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

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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