Overview

This trial is active, not recruiting.

Condition proliferative diabetic retinopathy
Treatments intravitreal injection of conbercept, prp
Sponsor Sun Yat-sen University
Start date September 2016
End date December 2019
Trial size 226 participants
Trial identifier NCT02911311, CONTINENT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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
intravitreal injection of conbercept KH-902 (Chengdu Kanghong Biotech Co., Ltd., Sichuan, China)
conbercept is an anti-VEGF agent and is approved by the Food and Drug Administration for wet age-related macular degeneration
(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
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 Outcomes

Measure
The primary outcome is mean visual acuity change(BCVA)
time frame: 12 months

Secondary Outcomes

Measure
Visual acuity outcomes in terms of visual gain or loss
time frame: 6 months and 12 months
the regression patterns of new vessels
time frame: 6 months and 12 months
proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy
time frame: 12 months
change of visual field
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy
Principal investigator Chenjin Jin, Dr.
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.