Vitreomacular Traction (VMT)Phase 2NCT07910630
A Phase II Study Evaluating the Efficacy and Safety of Recombinant Human Truncated Plasmin Injection (JZB32) in Patients With Vitreomacular Traction
A Phase 2 study testing Recombinant Human Truncated Plasmin Injection (JZB32) in people with Vitreomacular Traction (VMT), run by Jiangsu Jingze Biopharmaceutical Co., Ltd. at 15 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreomacular Traction (VMT)
- What is being tested?
- Recombinant Human Truncated Plasmin Injection (JZB32)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 15 sitesChina
- Study dates
- 8 Sep 2026to 30 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of an epiretinal membrane (ERM) coinciding with vitreomacular traction (VMT) in the study eye.
- Diameter of the macular hole > 400 μm in the study eye (applicable if a full-thickness macular hole is present in the study eye).
- Axial length > 28 mm in the study eye.
- 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.
- 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.
- 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.
- 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.
- Active or suspected ocular or periocular infection in either eye (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis).
- 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).
- 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.
- 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.
- 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).
- Known hypersensitivity or contraindications to the investigational drug or any of its components, or to required study medications (e.g., anesthetics, mydriatics, antibiotics).
- 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.
- Unwillingness or failure to use effective contraception during the study period;
- Note: The following conditions are not grounds for exclusion:
- Natural menopause defined as amenorrhea for ≥12 months;
- Bilateral oophorectomy, with or without hysterectomy, performed ≥6 weeks prior;
- Use of one or more of the following acceptable methods of contraception:
- Sterilization;
- Hormonal contraception;
- Intrauterine device (IUD);
- Double-barrier methods;
- Ability to maintain reliable contraception throughout the study period.
- Pregnant (defined as a positive urine or serum pregnancy test) or lactating females.
- Any other conditions or factors that, in the opinion of the investigator, render the participant unsuitable for the study.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
- Recruiting
The Second Hospital of Jilin University
Changchun, Jilin
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine (SAHZU)
Hangzhou, Zhejiang
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui
- Recruiting
The Second Hospital of Lanzhou University
Lanzhou, Gansu
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
- Recruiting
Shenzhen Eye Hospital
Shenzhen, Guangdong
- Recruiting
Shijiazhuang People's Hospital
Shijiazhuang, Hebei
- Recruiting
Shanxi Eye Hospital, China
Taiyuan, Shanxi
- Recruiting
Eye Hospital, Wenzhou Medical University (Zhejiang Eye Hospital)
Wenzhou, Zhejiang
- Recruiting
Central Theater Command General Hospital of the Chinese People's Liberation Army
Wuhan, Hubei
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei
- Recruiting
The First Hospital of Xi'an
Xi'an, Shaanxi
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Vitreomacular Traction (VMT)
- Being tested
- Recombinant Human Truncated Plasmin Injection (JZB32), Sham injection
- Keywords
- Vitreomacular Traction, VMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Truncated Plasmin Injection (JZB32)Drug
Single intravitreal injection of JZB32
Sham injectionOther
Single sham intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| JZB32 Group | Experimental | Recombinant Human Truncated Plasmin Injection (JZB32) Receives: Drug: Recombinant Human Truncated Plasmin Injection (JZB32) |
| Sham Injection Group | Sham comparator | Sham injection control Receives: Other: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of study eyes with resolution of vitreomacular traction (VMT) assessed by OCT
An efficacy outcome measure evaluating the rate of vitreomacular traction (VMT) resolution in the study eye using optical coherence tomography (OCT) at Day 28.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start8 Sep 2026
- Primary completion28 Dec 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreomacular Traction (VMT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Jingze Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910630
- Sponsor's protocol ID
- JZB32VMT201
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07910630
- Acronym / sponsor ID
- JZB32VMT201
- Conditions
- Vitreomacular Traction (VMT)
- Keywords
- Vitreomacular Traction, VMT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jiangsu Jingze Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JZB32 Group | Experimental | Drug: Recombinant Human Truncated Plasmin Injection (JZB32)Recombinant Human Truncated Plasmin Injection (JZB32) |
| Sham Injection Group | Sham comparator | Other: Sham injectionSham injection control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (27 listed)
- Presence of an epiretinal membrane (ERM) coinciding with vitreomacular traction (VMT) in the study eye.
- Diameter of the macular hole > 400 μm in the study eye (applicable if a full-thickness macular hole is present in the study eye).
- Axial length > 28 mm in the study eye.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Truncated Plasmin Injection (JZB32)Single intravitreal injection of JZB32 | Drug | JZB32 Group |
| Sham injectionSingle sham intravitreal injection | Other | Sham Injection Group |
Primary outcome
Percentage of study eyes with resolution of vitreomacular traction (VMT) assessed by OCT
Time frame: Day 28
An efficacy outcome measure evaluating the rate of vitreomacular traction (VMT) resolution in the study eye using optical coherence tomography (OCT) at Day 28.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Truncated Plasmin Injection (JZB32) in people with Vitreomacular Traction (VMT), run by Jiangsu Jingze Biopharmaceutical Co., Ltd. at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ms. Mo (86-18081801796, moli@jingzepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of study eyes with resolution of vitreomacular traction (VMT) assessed by OCT (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.