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- Klinische proef NCT03506750
Day Regimes of CONbercept on CytokinEs of PDR Patients Undergoing Vitrectomy - Trial (CONCEPT) (CONCEPT)
Different Day Regimes of Preoperative CONbercept Administration on CytokinEs of Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy: a Prospective Randomized Controlled Clinical Trial (CONCEPT)
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Proliferative diabetic retinopathy (PDR), characterized by neovascularization and fibrous proliferation, is a severe and common complication of diabetes mellitus (DM). Persistent vitreous hemorrhage (VH) caused by neovascularization and tractional retinal detachment (TRD) caused by fibrous proliferation can lead to permanent vision loss or even blindness, which are the most common indications for surgical intervention.
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).
Studietype
Inschrijving (Verwacht)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Werving
- First Affiliated Hospital of Nanjing Medical University
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Contact:
- Zizhong Hu, Dr
- Telefoonnummer: 15195960100
- E-mail: huzizhong@njmu.edu.cn
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 18 years or older
- 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:
- previous retinal vein occlusion.
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: IVC-1day
patients with proliferative diabetic retinopathy receiving IVC 1 days before surgery
|
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.
Initial blood and aqueous humor will be harvested at the time of IVC.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
|
Experimenteel: IVC-2day
patients with proliferative diabetic retinopathy receiving IVC 2 days before surgery
|
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.
Initial blood and aqueous humor will be harvested at the time of IVC.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
|
Experimenteel: IVC-3day
patients with proliferative diabetic retinopathy receiving IVC 3 days before surgery
|
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.
Initial blood and aqueous humor will be harvested at the time of IVC.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
|
Experimenteel: IVC-4day
patients with proliferative diabetic retinopathy receiving IVC 4 days before surgery
|
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.
Initial blood and aqueous humor will be harvested at the time of IVC.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
|
Experimenteel: IVC-5day
patients with proliferative diabetic retinopathy receiving IVC 5 days before surgery
|
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.
Initial blood and aqueous humor will be harvested at the time of IVC.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
|
Experimenteel: IVC-6day
patients with proliferative diabetic retinopathy receiving IVC 6 days before surgery
|
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.
Initial blood and aqueous humor will be harvested at the time of IVC.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
|
Experimenteel: IVC-7day
patients with proliferative diabetic retinopathy receiving IVC 7 days before surgery
|
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.
Initial blood and aqueous humor will be harvested at the time of IVC.
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
|
Sham-vergelijker: IVC-sham
patients with proliferative diabetic retinopathy receiving sham IVC
|
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
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.
|
Placebo-vergelijker: non-DR
patients with other retinopathy (idiopathic macular hole or epiretinal membrane)
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Blood, aqueous humor, and vitreous will be collected at the time of surgery.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Changes of intraocular VEGF and PLGF of patients with proliferative diabetic retinopathy post-IVC (intravitreous injection of Conbercept).
Tijdsspanne: 1-7 days
|
1-7 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Changes of serum angiogenesis-related pro-cytokines in patients with proliferative diabetic retinopathy
Tijdsspanne: 1-7 days
|
1-7 days
|
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Changes of intraocular and serum profibrotic cytokines in patients with proliferative diabetic retinopathy post-IVC.
Tijdsspanne: 1-7 days
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1-7 days
|
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Changes of intraocular and serum inflammatory cytokines in patients with proliferative diabetic retinopathy post-IVC.
Tijdsspanne: 1-7 days
|
1-7 days
|
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Vitreous concentration of Conbercept
Tijdsspanne: 1-7 days
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Detection of Vitreous concentration of the drug of Conbercept (Conbercept is a kind of fusion protein)
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1-7 days
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Effect of IVC on surgery time of surgery
Tijdsspanne: Surgery day
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surgery time of vitrectomy
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Surgery day
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Effect of IVC on intraoperative complication of surgery
Tijdsspanne: Surgery day
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Record the intraoperative complication: bleeding and iatrogenic retinal hole when surgically removing the proliferative membranes.
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Surgery day
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Effect of IVC on regression of neovascularization on vitreous fibrovascular membrane with optic coherence tomography angiography (OCTA)
Tijdsspanne: 1 to 7 days
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OCTA monitor the changes of neovascularization on vitreous fibrovascular membrane after IVC and before surgery
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1 to 7 days
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Effect of IVC on postoperative visual acuity
Tijdsspanne: 1 to12 months
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Best-corrected visual acuity postoperatively
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1 to12 months
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Effect of IVC on postoperative complications
Tijdsspanne: 1 to12 months
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Record number of patient with vitreous re-bleeding and iris neovascularization postoperatively.
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1 to12 months
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Qinghuai Liu, The First Affiliated Hospital with Nanjing Medical University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CONCEPT
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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