Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy

Not Applicable

• Conditions: Proliferative Diabetic Retinopathy
• Interventions: Drug: intravitreal injection of conbercept; Device: PRP

• Registration Number: NCT02911311
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-09-17
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Study Start: 2019-10-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-25
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 226

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVC group	intravitreal injection of conbercept	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
PRP group	PRP	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

Primary Outcome Measures

Name	Time	Method
The primary outcome is mean visual acuity change(BCVA)	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

Name	Time	Method
the regression patterns of new vessels	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
Visual acuity outcomes in terms of visual gain or loss	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
proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy	12 months	proportion of patients developing macular oedema, vitreous haemorrhage and vitrectomy at months
change of visual field	12 months	change of visual field will be evaluated by the perimeter
change of retinal function	12 months	change of retinal function measured by electroretinography(ERG)
change of macular capillary density	12 months	change of macular capillary density measured by Optical coherence tomography angiography
change of central retinal thickness	12 months	change of central retinal thickness measured by Optical coherence tomography

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China