Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy

NCT02911311 | Unknown DMC

• 1 other identifier: CONTINENT
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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.

Conditions

Proliferative Diabetic Retinopathy

Keywords

conbercept; anti-VEGF agent; panretinal photocoagulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Visual acuity outcomes in terms of visual gain or loss

  6 months and 12 months

• the regression patterns of new vessels

  6 months and 12 months

• proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy

  12 months

• change of visual field

  12 months

• change of retinal function

  12 months

Study Arms (2)

IVC group

EXPERIMENTAL

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

PRP group

ACTIVE COMPARATOR

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

Interventions

intravitreal injection of conbercept DRUG

conbercept is an anti-VEGF agent and is approved by the Food and Drug Administration for wet age-related macular degeneration

Also known as: KH-902 (Chengdu Kanghong Biotech Co., Ltd., Sichuan, China)

IVC group

PRP DEVICE

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

PRP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related 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.

  PMID: 26565927 BACKGROUND

Related Links

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

MeSH Terms

Interventions

KH902 fusion protein; Long-Term Synaptic Depression

Intervention Hierarchy (Ancestors)

Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chenjin Jin, Dr.

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of ophthalmology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 17, 2016
• First Posted: September 22, 2016
• Study Start: October 12, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

CN (1)