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Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intravitreal injection of conbercept
PRP
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring conbercept, anti-VEGF agent, panretinal photocoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IVC group

PRP group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy
proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy at months
change of visual field
change of visual field will be evaluated by the perimeter
change of retinal function
change of retinal function measured by electroretinography(ERG)
change of macular capillary density
change of macular capillary density measured by Optical coherence tomography angiography
change of central retinal thickness
change of central retinal thickness measured by Optical coherence tomography

Full Information

First Posted
September 17, 2016
Last Updated
February 22, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02911311
Brief Title
Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy
Official Title
Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 12, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
conbercept, anti-VEGF agent, panretinal photocoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
226 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVC group
Arm Type
Experimental
Arm Description
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
Arm Title
PRP group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
intravitreal injection of conbercept
Other Intervention Name(s)
KH-902 (Chengdu Kanghong Biotech Co., Ltd., Sichuan, China)
Intervention Description
conbercept is an anti-VEGF agent and is approved by the Food and Drug Administration for wet age-related macular degeneration
Intervention Type
Device
Intervention Name(s)
PRP
Intervention Description
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 Measure Information:
Title
The primary outcome is mean visual acuity change(BCVA)
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Visual acuity outcomes in terms of visual gain or loss
Description
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
Time Frame
6 months and 12 months
Title
the regression patterns of new vessels
Description
the complete regression proportion of new retinal vessels is evaluated by the fundus photography and fundus fluorescein angiography at 6 months and 12 months
Time Frame
6 months and 12 months
Title
proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy
Description
proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy at months
Time Frame
12 months
Title
change of visual field
Description
change of visual field will be evaluated by the perimeter
Time Frame
12 months
Title
change of retinal function
Description
change of retinal function measured by electroretinography(ERG)
Time Frame
12 months
Title
change of macular capillary density
Description
change of macular capillary density measured by Optical coherence tomography angiography
Time Frame
12 months
Title
change of central retinal thickness
Description
change of central retinal thickness measured by Optical coherence tomography
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants of either sex aged 18 years or over. Diagnosis of diabetes mellitus (type 1 or 2). Best-corrected visual acuity (BCVA) in the study eye better than or equal to 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters PDR with no evidence of previous PRP. Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs. Exclusion Criteria: a glycated haemoglobin (HbA1c) level of more than 10%; Blood pressure > 180/100 mmHg Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months dialysis or renal transplant Systemic anti-VEGF or pro-VEGF treatment within 6 months prior to randomization For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years Traction retinal detachment involving the macula Exam evidence of neovascularization of the angle History of major ocular surgery or anticipated within the next 6 months following randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenjin Jin, Dr.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26565927
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/26565927
Description
Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial

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Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy

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