A Study Evaluating the Efficacy and Safety of Recombinant Human Truncated Plasmin Injection (JZB32) in Patients With Vitreomacular Traction
A Randomized, Double-Blind, Multicenter, Sham Injection-Controlled, Parallel-Group Phase II Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Truncated Plasmin Injection (JZB32) in Patients With Vitreomacular Traction
This study aims to evaluate the efficacy of JZB32 in patients with vitreomacular traction (VMT). Based on a randomized, double-blind, multicenter, sham injection-controlled, parallel-group design, the proportion of study eyes achieving VMT resolution assessed by optical coherence tomography (OCT) at Day 28 will be compared between the JZB32 group and the sham injection group.
연구 개요
상태
상세 설명
Currently, there are no effective pharmacological treatments available for patients with vitreomacular traction (VMT). Management options are primarily limited to "watchful waiting" and pars plana vitrectomy (PPV), which carries potential complications. This study will evaluate the efficacy of JZB32 in patients with VMT by comparing the rate of OCT-assessed VMT resolution in study eyes at Day 28 (D28) between JZB32 and sham injection.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Ms. Mo
- 전화번호: 86-18081801796
- 이메일: moli@jingzepharma.com
연구 장소
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Anhui
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Hefei, Anhui, 중국
- 모병
- The Second Hospital of Anhui Medical University
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Beijing Municipality
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Beijing, Beijing Municipality, 중국
- 모병
- Beijing Tongren Hospital, Capital Medical University
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Gansu
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Lanzhou, Gansu, 중국
- 모병
- The Second Hospital of Lanzhou University
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Guangdong
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Shenzhen, Guangdong, 중국
- 모병
- Shenzhen Eye Hospital
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Guangxi
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Nanning, Guangxi, 중국
- 모병
- The People's Hospital of Guangxi Zhuang Autonomous Region
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Hebei
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Shijiazhuang, Hebei, 중국
- 모병
- Shijiazhuang People's Hospital
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Hubei
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Wuhan, Hubei, 중국
- 모병
- Renmin Hospital of Wuhan University
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Wuhan, Hubei, 중국
- 모병
- Central Theater Command General Hospital of the Chinese People's Liberation Army
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Jilin
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Changchun, Jilin, 중국
- 모병
- The Second Hospital of Jilin University
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Shaanxi
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Xi'an, Shaanxi, 중국
- 모병
- The First Hospital of Xi'an
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Shanxi
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Taiyuan, Shanxi, 중국
- 모병
- Shanxi Eye Hospital, China
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Sichuan
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Chengdu, Sichuan, 중국
- 모병
- West China Hospital, Sichuan University
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Zhejiang
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Hangzhou, Zhejiang, 중국
- 모병
- Zhejiang Provincial People's Hospital
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Hangzhou, Zhejiang, 중국
- 모병
- The Second Affiliated Hospital, Zhejiang University School of Medicine (SAHZU)
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Wenzhou, Zhejiang, 중국
- 모병
- Eye Hospital, Wenzhou Medical University (Zhejiang Eye Hospital)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Aged≥18 years at the time of signing the informed consent form, regardless of gender.
- Vitreomacular traction (VMT) in the study eye confirmed by optical coherence tomography (OCT), defined as attachment of the posterior vitreous cortex to the retinal surface within a 3 mm radius of the fovea, resulting in abnormalities such as foveal deformation, elevation, or alterations in retinal morphology and structure.
- Best-Corrected Visual Acuity (BCVA) in the study eye of ≤ 20/25 (≤ 83 letters) and in the non-study eye of ≥ 20/400 (≥19 letters), measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart.
- Capable of understanding and willing to participate in the study, with informed consent signed by the participant or their legally authorized representative, and willing to comply with the treatment schedule and attend all scheduled follow-up visits as required by the protocol.
Exclusion Criteria:
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Presence of an epiretinal membrane (ERM) coinciding with vitreomacular traction (VMT) in the study eye.
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Diameter of the macular hole > 400 μm in the study eye (applicable if a full-thickness macular hole is present in the study eye).
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Axial length > 28 mm in the study eye.
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Presence of other ocular conditions in the study eye that may confound the interpretation of study results or require urgent treatment, including but not limited to: proliferative diabetic retinopathy (PDR); central retinal vein occlusion (CRVO); branch retinal vein occlusion (BRVO); wet age-related macular degeneration (wAMD); choroidal neovascularization (CNV); uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite anti-glaucoma treatment), or a cup-to-disc ratio > 0.8 in the study eye caused by glaucoma.
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Presence of other ocular media opacities in the study eye, such as leukoma, cataract, vitreous opacity/hemorrhage, or posterior iris synechiae, which, in the opinion of the investigator, would interfere with OCT, BCVA, fundus examination, or intravitreal injection procedures.
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Presence of pseudoexfoliation syndrome, Marfan syndrome, aphakia, or any other condition in the study eye judged by the investigator to cause zonular instability.
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History of retinal detachment in the study eye.
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History of non-pharmacological therapies in the study eye: prior vitrectomy, macular laser photocoagulation, fundus surgery, ab externo ocular surgery, or anti-glaucoma surgery; cataract surgery within 90 days prior to injection; intravitreal injection or laser procedures (e.g., retinal photocoagulation, laser iridotomy, posterior capsulotomy) within 30 days prior to injection; or ocular surface surgery (e.g., entropion repair, pterygium excision) within 30 days prior to injection.
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Active or suspected ocular or periocular infection in either eye (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis).
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Uncontrolled psychiatric disorders, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary dysfunction, severe hepatic or renal impairment, malignant tumors, hypertension, or diabetes mellitus at screening (unless judged eligible by the investigator).
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Positive screening for Hepatitis B (defined as HBsAg positive and HBV-DNA ≥ 2000 IU/mL), Hepatitis C (defined as anti-HCV positive and HCV-RNA positive), Human Immunodeficiency Virus (HIV) antibodies, or Treponema pallidum (Anti-TP) specific antibodies.
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Use of plasmin or plasminogen activator drugs (e.g., alteplase) systemically or topically in the eye within 30 days prior to injection, or potential need for such treatment during the study period.
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Current use or anticipated need during the study period of medications known to cause lens, retinal, or optic nerve toxicity (e.g., deferoxamine, chloroquine, hydroxychloroquine, tamoxifen, phenothiazines, or ethambutol).
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Known hypersensitivity or contraindications to the investigational drug or any of its components, or to required study medications (e.g., anesthetics, mydriatics, antibiotics).
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Participation in any drug (excluding vitamins and minerals) or medical device clinical trial within 30 days prior to injection and receipt of study drug or device. If 5 half-lives of the investigational drug exceeds 30 days, 5 half-lives shall apply.
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Unwillingness or failure to use effective contraception during the study period;
Note: The following conditions are not grounds for exclusion:
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Natural menopause defined as amenorrhea for ≥12 months;
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Bilateral oophorectomy, with or without hysterectomy, performed ≥6 weeks prior;
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Use of one or more of the following acceptable methods of contraception:
- Sterilization;
- Hormonal contraception;
- Intrauterine device (IUD);
- Double-barrier methods;
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Ability to maintain reliable contraception throughout the study period.
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Pregnant (defined as a positive urine or serum pregnancy test) or lactating females.
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Any other conditions or factors that, in the opinion of the investigator, render the participant unsuitable for the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: JZB32 Group
Recombinant Human Truncated Plasmin Injection (JZB32) |
Single intravitreal injection of JZB32 |
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가짜 비교기: Sham Injection Group
Sham injection control |
Single sham intravitreal injection |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of study eyes with resolution of vitreomacular traction (VMT) assessed by OCT
기간: Day 28
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An efficacy outcome measure evaluating the rate of vitreomacular traction (VMT) resolution in the study eye using optical coherence tomography (OCT) at Day 28. |
Day 28
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
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개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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