Day Regimes of CONbercept on CytokinEs of PDR Patients Undergoing Vitrectomy - Trial (CONCEPT)

NCT03506750 | Unknown Phase 4 DMC

• 1 other identifier: CONCEPT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with proliferative diabetic retinopathy requiring surgical intervention will receive a pre-operative injection of Conbercept. Patients will be recruited into different groups according to variable time intervals (1 to 7 days) between intravitreous injection and surgery. At initial, pre-injection aqueous humor and blood sample will be collected in order to provide baseline VEGF-A, -B, placental growth factor (PIGF), and other cytokine levels. At the onset of the vitrectomy, a second aqueous humor, blood, and vitreous sample will be taken to obtain intra-operative levels of , VEGF-A, -B, PIGF, and other cytokine levels.

Conditions

Proliferative Diabetic Retinopathy; VEGF Overexpression

Keywords

Conbercept; PLGF

Outcome Measures

Primary Outcomes (1)

• Changes of intraocular VEGF and PLGF of patients with proliferative diabetic retinopathy post-IVC (intravitreous injection of Conbercept).

  1-7 days

Secondary Outcomes (9)

• Changes of serum angiogenesis-related pro-cytokines in patients with proliferative diabetic retinopathy

  1-7 days

• Changes of intraocular and serum profibrotic cytokines in patients with proliferative diabetic retinopathy post-IVC.

  1-7 days

• Changes of intraocular and serum inflammatory cytokines in patients with proliferative diabetic retinopathy post-IVC.

  1-7 days

• Vitreous concentration of Conbercept

  1-7 days

• Effect of IVC on surgery time of surgery

  Surgery day

Study Arms (9)

IVC-1day

EXPERIMENTAL

patients with proliferative diabetic retinopathy receiving IVC 1 days before surgery

Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.

IVC-2day

EXPERIMENTAL

patients with proliferative diabetic retinopathy receiving IVC 2 days before surgery

Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.

IVC-3day

EXPERIMENTAL

patients with proliferative diabetic retinopathy receiving IVC 3 days before surgery

Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.

IVC-4day

EXPERIMENTAL

patients with proliferative diabetic retinopathy receiving IVC 4 days before surgery

Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.

IVC-5day

EXPERIMENTAL

patients with proliferative diabetic retinopathy receiving IVC 5 days before surgery

Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.

IVC-6day

EXPERIMENTAL

patients with proliferative diabetic retinopathy receiving IVC 6 days before surgery

Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.

IVC-7day

EXPERIMENTAL

patients with proliferative diabetic retinopathy receiving IVC 7 days before surgery

Drug: IVC; Procedure: Blood and aqueous humor at the time of IVC; Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.

IVC-sham

SHAM COMPARATOR

patients with proliferative diabetic retinopathy receiving sham IVC

Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.; Procedure: IVC-sham

non-DR

PLACEBO COMPARATOR

patients with other retinopathy (idiopathic macular hole or epiretinal membrane)

Procedure: Collect blood, aqueous humor, and initial vitreous at the time of surgery.

Interventions

IVC DRUG

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.

IVC-1day; IVC-2day; IVC-3day; IVC-4day; IVC-5day; IVC-6day; IVC-7day

Blood and aqueous humor at the time of IVC PROCEDURE

Initial blood and aqueous humor will be harvested at the time of IVC.

IVC-1day; IVC-2day; IVC-3day; IVC-4day; IVC-5day; IVC-6day; IVC-7day

Collect blood, aqueous humor, and initial vitreous at the time of surgery. PROCEDURE

Blood, aqueous humor, and vitreous will be collected at the time of surgery.

IVC-1day; IVC-2day; IVC-3day; IVC-4day; IVC-5day; IVC-6day; IVC-7day; IVC-sham; non-DR

IVC-sham PROCEDURE

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.

IVC-sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 33586674 DERIVED

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Qinghuai Liu

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Zizhong Hu, Dr

CONTACT

15195960100; huzizhong@njmu.edu.cn

Ping Xie

CONTACT

13915975130; xieping9@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: April 24, 2018
• Study Start: June 3, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 31, 2018
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

CN (1)