Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy

Sun Yat-sen University226 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

226

Conditions

Proliferative Diabetic Retinopathy

Interventions

intravitreal injection of conberceptDRUG

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

PRPDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 12 months

change of visual field

change of visual field will be evaluated by the perimeter

Time frame: 12 months

change of retinal function

change of retinal function measured by electroretinography(ERG)

Time frame: 12 months

change of macular capillary density

change of macular capillary density measured by Optical coherence tomography angiography

Time frame: 12 months

Data from ClinicalTrials.gov

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