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)
調査の概要
状態
詳細な説明
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).
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前:Zizhong Hu, Dr
- 電話番号:15195960100
- メール:huzizhong@njmu.edu.cn
研究連絡先のバックアップ
- 名前:Ping Xie
- 電話番号:13915975130
- メール:xieping9@126.com
研究場所
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210029
- 募集
- First Affiliated Hospital of Nanjing Medical University
-
コンタクト:
- Zizhong Hu, Dr
- 電話番号:15195960100
- メール:huzizhong@njmu.edu.cn
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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.
|
実験的: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.
|
実験的: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.
|
実験的: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.
|
実験的: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.
|
実験的: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.
|
実験的: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.
|
偽コンパレータ: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.
|
プラセボコンパレーター:non-DR
patients with other retinopathy (idiopathic macular hole or epiretinal membrane)
|
Blood, aqueous humor, and vitreous will be collected at the time of surgery.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Changes of intraocular VEGF and PLGF of patients with proliferative diabetic retinopathy post-IVC (intravitreous injection of Conbercept).
時間枠:1-7 days
|
1-7 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Changes of serum angiogenesis-related pro-cytokines in patients with proliferative diabetic retinopathy
時間枠:1-7 days
|
1-7 days
|
|
Changes of intraocular and serum profibrotic cytokines in patients with proliferative diabetic retinopathy post-IVC.
時間枠:1-7 days
|
1-7 days
|
|
Changes of intraocular and serum inflammatory cytokines in patients with proliferative diabetic retinopathy post-IVC.
時間枠:1-7 days
|
1-7 days
|
|
Vitreous concentration of Conbercept
時間枠:1-7 days
|
Detection of Vitreous concentration of the drug of Conbercept (Conbercept is a kind of fusion protein)
|
1-7 days
|
Effect of IVC on surgery time of surgery
時間枠:Surgery day
|
surgery time of vitrectomy
|
Surgery day
|
Effect of IVC on intraoperative complication of surgery
時間枠:Surgery day
|
Record the intraoperative complication: bleeding and iatrogenic retinal hole when surgically removing the proliferative membranes.
|
Surgery day
|
Effect of IVC on regression of neovascularization on vitreous fibrovascular membrane with optic coherence tomography angiography (OCTA)
時間枠:1 to 7 days
|
OCTA monitor the changes of neovascularization on vitreous fibrovascular membrane after IVC and before surgery
|
1 to 7 days
|
Effect of IVC on postoperative visual acuity
時間枠:1 to12 months
|
Best-corrected visual acuity postoperatively
|
1 to12 months
|
Effect of IVC on postoperative complications
時間枠:1 to12 months
|
Record number of patient with vitreous re-bleeding and iris neovascularization postoperatively.
|
1 to12 months
|
協力者と研究者
捜査官
- スタディディレクター:Qinghuai Liu、The First Affiliated Hospital with Nanjing Medical University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
IVCの臨床試験
-
Kasr El Aini HospitalMansoura University募集
-
University of Maryland, BaltimoreUnited States Air Force引きこもった
-
Rhode Island HospitalInternational Centre for Diarrhoeal Disease Research, Bangladesh; Fogarty International Center...完了
-
Isfahan University of Medical Sciences完了