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Trial record 2 of 16 for:    Diabetic Retinopathy | guangzhou, China

Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT02911311
Recruitment Status : Enrolling by invitation
First Posted : September 22, 2016
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Jin Chen-jin, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Drug: intravitreal injection of conbercept Device: PRP Not Applicable

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy
Actual Study Start Date : October 12, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IVC group
intravitreal injection of conbercept (IVC) group:all study eyes randomised to receive conbercept will receive an intravitreal injection of conbercept 2 mg/ 0.05 mL at baseline and at 1 and 2 moths. Further treatment since months 3 is determined by the degree of regression of neovascularization (NV) of disc and elsewhere on clinical examination
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
Other Name: KH-902 (Chengdu Kanghong Biotech Co., Ltd., Sichuan, China)

Active Comparator: PRP group
panretinal photocoagulation (PRP) group:all study eyes randomised to receive PRP will receive an fill-in PRP in 1-2 two weekly sessions as per routine clinical practice with emphasis on targeting retinal nonperfusion areas
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




Primary Outcome Measures :
  1. The primary outcome is mean visual acuity change(BCVA) [ Time Frame: 12 months ]
    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


Secondary Outcome Measures :
  1. Visual acuity outcomes in terms of visual gain or loss [ Time Frame: 6 months and 12 months ]
    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

  2. the regression patterns of new vessels [ Time Frame: 6 months and 12 months ]
    the complete regression proportion of new retinal vessels is evaluated by the fundus photography and fundus fluorescein angiography at 6 months and 12 months

  3. proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy [ Time Frame: 12 months ]
    proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy at months

  4. change of visual field [ Time Frame: 12 months ]
    change of visual field will be evaluated by the perimeter

  5. change of retinal function [ Time Frame: 12 months ]
    change of retinal function measured by electroretinography(ERG)

  6. change of macular capillary density [ Time Frame: 12 months ]
    change of macular capillary density measured by Optical coherence tomography angiography

  7. change of central retinal thickness [ Time Frame: 12 months ]
    change of central retinal thickness measured by Optical coherence tomography



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911311


Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Chenjin Jin, Dr. Zhongshan Ophthalmic Center, Sun Yat-sen University
Additional Information:
Publications:
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Responsible Party: Jin Chen-jin, Director of ophthalmology, Principal Investigator, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02911311    
Other Study ID Numbers: CONTINENT
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin Chen-jin, Sun Yat-sen University:
conbercept
anti-VEGF agent
panretinal photocoagulation
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases