Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy

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.

Study Overview

• Status: Unknown
• Conditions: Proliferative Diabetic Retinopathy
• Intervention / Treatment: Drug: intravitreal injection of conbercept; Device: 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

• Study Type: Interventional
• Enrollment (Anticipated): 226
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy	proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy at months	12 months
change of visual field	change of visual field will be evaluated by the perimeter	12 months
change of retinal function	change of retinal function measured by electroretinography(ERG)	12 months
change of macular capillary density	change of macular capillary density measured by Optical coherence tomography angiography	12 months
change of central retinal thickness	change of central retinal thickness measured by Optical coherence tomography	12 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Chenjin Jin, Dr., Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 17, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (Estimate): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: panretinal photocoagulation; conbercept; anti-VEGF agent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: CONTINENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No