Day Regimes of CONbercept on CytokinEs of PDR Patients Undergoing Vitrectomy - Trial (CONCEPT)
NCT ID: NCT03506750
Last Updated: 2018-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2017-06-03
2018-12-31
Brief Summary
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Detailed Description
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As neovascularization is the basal pathophysiological change of PDR and vascular endothelial growth factor (VEGF) has been acknowledged as primary angiogenesis factor, the preoperative adjunctive use of VEGF blockade is rationally proposed. The anti-VEGF drugs have been reported to be effective in bringing about regression of retinal neovascularization, shortening surgical duration, avoiding risk of iatrogenic retinal hole and secondary operation for the recurrent VH.
Conbercept (KH902) is a newly developed anti-VEGF drug and has been applied in clinic. Because of its additional binding domain of VEGFR-2, conbercept can bind to all isoforms of VEGF-A, VEGF-B, and placental growth factor (PLGF). A number of studies have presented its high affinity in the treatment of fundus diseases such as wet age-related macular degeneration (wet-AMD), macular edema secondary to retinal vein occlusion\[8\] and diabetic retinopathy. Also, recent randomized controlled trials have shown its protective effect of conbercept for the surgical treatment of PDR.
Although the overwhelming clinical evidence supports the anti-VEGF drugs as the preoperative adjuncts for PDR, the optimal duration between anti-VEGF injection and surgical intervention has not yet reached a consensus. Longer duration is related to higher incidence of the development or progression of TRD. It might provide clues by investigation of the pattern of cytokine changes in humor aqueous, vitreous, and blood. No studies have been done to date in patients with PDR to quantify the reduction of intravitreal VEGF-A, -B, PLGF or other cytokines levels in these patients following intravitreal Conbercept injection or to evaluate the effects of VEGF or PIGF blockade on the neovascular regression and surgical outcome in patients with extensive diabetic proliferative neovascularization.
The goal of this study is to quantify the reduction of changes of VEGF-A, -B, PLGF levels in patients receiving r pre-operative intravitreal Conbercept after variable time intervals (1, 2, 3, 4, 5, 6, 7 days).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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IVC-1day
patients with proliferative diabetic retinopathy receiving IVC 1 days before surgery
IVC
Patients with PDR will receive intravitreal injection of conbercept (0.5 mg/0.05 mL; Chengdu Kanghong Biotech, Inc., Chengdu, Sichuan, China) in the inferior-temporal sector 4 mm from the sclerocorneal limbus before pars plana vitrectomy (PPV) surgery.
Blood and aqueous humor at the time of IVC
Initial blood and aqueous humor will be harvested at the time of IVC.
Collect blood, aqueous humor, and initial vitreous at the time of surgery.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
IVC-2day
patients with proliferative diabetic retinopathy receiving IVC 2 days before surgery
IVC
Patients with PDR will receive intravitreal injection of conbercept (0.5 mg/0.05 mL; Chengdu Kanghong Biotech, Inc., Chengdu, Sichuan, China) in the inferior-temporal sector 4 mm from the sclerocorneal limbus before pars plana vitrectomy (PPV) surgery.
Blood and aqueous humor at the time of IVC
Initial blood and aqueous humor will be harvested at the time of IVC.
Collect blood, aqueous humor, and initial vitreous at the time of surgery.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
IVC-3day
patients with proliferative diabetic retinopathy receiving IVC 3 days before surgery
IVC
Patients with PDR will receive intravitreal injection of conbercept (0.5 mg/0.05 mL; Chengdu Kanghong Biotech, Inc., Chengdu, Sichuan, China) in the inferior-temporal sector 4 mm from the sclerocorneal limbus before pars plana vitrectomy (PPV) surgery.
Blood and aqueous humor at the time of IVC
Initial blood and aqueous humor will be harvested at the time of IVC.
Collect blood, aqueous humor, and initial vitreous at the time of surgery.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
IVC-4day
patients with proliferative diabetic retinopathy receiving IVC 4 days before surgery
IVC
Patients with PDR will receive intravitreal injection of conbercept (0.5 mg/0.05 mL; Chengdu Kanghong Biotech, Inc., Chengdu, Sichuan, China) in the inferior-temporal sector 4 mm from the sclerocorneal limbus before pars plana vitrectomy (PPV) surgery.
Blood and aqueous humor at the time of IVC
Initial blood and aqueous humor will be harvested at the time of IVC.
Collect blood, aqueous humor, and initial vitreous at the time of surgery.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
IVC-5day
patients with proliferative diabetic retinopathy receiving IVC 5 days before surgery
IVC
Patients with PDR will receive intravitreal injection of conbercept (0.5 mg/0.05 mL; Chengdu Kanghong Biotech, Inc., Chengdu, Sichuan, China) in the inferior-temporal sector 4 mm from the sclerocorneal limbus before pars plana vitrectomy (PPV) surgery.
Blood and aqueous humor at the time of IVC
Initial blood and aqueous humor will be harvested at the time of IVC.
Collect blood, aqueous humor, and initial vitreous at the time of surgery.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
IVC-6day
patients with proliferative diabetic retinopathy receiving IVC 6 days before surgery
IVC
Patients with PDR will receive intravitreal injection of conbercept (0.5 mg/0.05 mL; Chengdu Kanghong Biotech, Inc., Chengdu, Sichuan, China) in the inferior-temporal sector 4 mm from the sclerocorneal limbus before pars plana vitrectomy (PPV) surgery.
Blood and aqueous humor at the time of IVC
Initial blood and aqueous humor will be harvested at the time of IVC.
Collect blood, aqueous humor, and initial vitreous at the time of surgery.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
IVC-7day
patients with proliferative diabetic retinopathy receiving IVC 7 days before surgery
IVC
Patients with PDR will receive intravitreal injection of conbercept (0.5 mg/0.05 mL; Chengdu Kanghong Biotech, Inc., Chengdu, Sichuan, China) in the inferior-temporal sector 4 mm from the sclerocorneal limbus before pars plana vitrectomy (PPV) surgery.
Blood and aqueous humor at the time of IVC
Initial blood and aqueous humor will be harvested at the time of IVC.
Collect blood, aqueous humor, and initial vitreous at the time of surgery.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
IVC-sham
patients with proliferative diabetic retinopathy receiving sham IVC
Collect blood, aqueous humor, and initial vitreous at the time of surgery.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
IVC-sham
Patients with PDR will receive sham intravitreal injection of conbercept in the inferior-temporal sector 4 mm from the sclerocorneal limbus 4 days before PPV surgery.
non-DR
patients with other retinopathy (idiopathic macular hole or epiretinal membrane)
Collect blood, aqueous humor, and initial vitreous at the time of surgery.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
Interventions
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IVC
Patients with PDR will receive intravitreal injection of conbercept (0.5 mg/0.05 mL; Chengdu Kanghong Biotech, Inc., Chengdu, Sichuan, China) in the inferior-temporal sector 4 mm from the sclerocorneal limbus before pars plana vitrectomy (PPV) surgery.
Blood and aqueous humor at the time of IVC
Initial blood and aqueous humor will be harvested at the time of IVC.
Collect blood, aqueous humor, and initial vitreous at the time of surgery.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
IVC-sham
Patients with PDR will receive sham intravitreal injection of conbercept in the inferior-temporal sector 4 mm from the sclerocorneal limbus 4 days before PPV surgery.
Eligibility Criteria
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Inclusion Criteria
* Type 1 or 2 diabetes
* PDR patients requiring surgical intervention for complications of vitreous hemorrhage or traction retinal detachment and pre-operative IVC treatment.
* women postmenopausal for 12 months before the study, surgically sterile, or not pregnant and on effective contraception.
Exclusion Criteria
* any intraocular surgery within the previous 12 months.
* myopia of \> or = to 8 diopters.
* active ocular or periocular infection
* treatment with an investigational agent for any condition 60 days prior to enrollment.
* evidence of severe cardiac disease.
* clinically significant peripheral vascular disease (previous surgery, amputation, or symptoms of claudication)
* uncontrolled hypertension (treated systolic blood pressure \> 155 mmHg or diastolic blood pressure \> 95 mmHg)
* stroke within the preceding 12 months.
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Zizhong Hu
Dr.
Principal Investigators
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Qinghuai Liu
Role: STUDY_DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Chen DY, Sun NH, Chen X, Gong JJ, Yuan ST, Hu ZZ, Lu NN, Korbelin J, Fukunaga K, Liu QH, Lu YM, Han F. Endothelium-derived semaphorin 3G attenuates ischemic retinopathy by coordinating beta-catenin-dependent vascular remodeling. J Clin Invest. 2021 Feb 15;131(4):e135296. doi: 10.1172/JCI135296.
Other Identifiers
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CONCEPT
Identifier Type: -
Identifier Source: org_study_id
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