Central Retinal Artery OcclusionNCT07151755
Microneedle Intra-Arterial Injection for Retinal Artery Occlusion
A study testing Standard Clinical Care Only in people with Central Retinal Artery Occlusion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This prospective interventional study evaluates the efficacy and safety of direct intra-arterial microneedle injection combined with pars plana vitrectomy for acute retinal artery occlusion (including central retinal artery occlusion [CRAO] and branch retinal artery occlusion [BRAO] involving the macula or causing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Artery Occlusion
- What is being tested?
- Standard Clinical Care Only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Jul 2027
- Phase
- Interventional
- 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
- Age ≥18 years
- Acute non-arteritic retinal artery occlusion (RAO), including: Central retinal artery occlusion (CRAO), or Branch retinal artery occlusion (BRAO) involving the macula or causing severe visual loss; defined as symptom onset ≤7 days and confirmed by exam ± imaging (FFA/OCT)
- Best-corrected visual acuity (BCVA) <0.5 (decimal)
Who cannot join
- Active bleeding disorder, or significant bleeding within the past 3 months, or bleeding diathesis
- Severe hypertension: SBP >185 mmHg or DBP >110 mmHg
- Severe coagulopathy or ongoing therapeutic anticoagulation
- Ischemic stroke within the past 3 months
- Severe, unstable systemic disease rendering surgery or anesthesia risk unacceptable
- Known hypersensitivity to thrombolytic agents or any study medications/materials
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- Active ocular infection
- Vitreous hemorrhage
- Retinal arteritis
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye Center of the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310058
Jian Ma, MD., +8618858299889, jian_ma@zju.edu.cn
About this study
Official title: Microneedle Intra-Arterial Injection With Pars Plana Vitrectomy for Acute Retinal Artery Occlusion: A Prospective Clinical Trial
This prospective interventional study evaluates the efficacy and safety of direct intra-arterial microneedle injection combined with pars plana vitrectomy for acute retinal artery occlusion (including central retinal artery occlusion [CRAO] and branch retinal artery occlusion [BRAO] involving the macula or causing severe visual loss). The primary endpoint is best-corrected visual acuity (BCVA, LogMAR) at 1 month. Secondary objectives include assessing the effect of treatment timing and monitoring longitudinal changes in visual function and retinal structure over 12 months.
Read the detailed description
Retinal artery occlusion lacks an established standard therapy. This prospective, non-randomized, parallel-group interventional trial compares pars plana vitrectomy with direct intra-arterial microneedle thrombolysis plus standard care (experimental arm) with standard clinical care alone (control arm). The trial is open-label, and outcome assessors for BCVA, automated perimetry, fluorescein angiography (FFA), and optical coherence tomography (OCT) will be masked. Scheduled visits occur at 1 week, 1 month, 3 months, 6 months, and 12 months. The symptom-to-treatment interval (≤3 days vs 3-7 days) is a prespecified subgroup for secondary analyses.
- Conditions
- Central Retinal Artery Occlusion
- Being tested
- Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care, Standard Clinical Care Only
- Keywords
- central retinal artery occlusion, microneedle, thrombolysis
- Medical subject headings
- Retinal Artery Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard CareProcedure or surgery
The patients will receive standard pars plana vitrectomy (PPV) combined with direct intra-arterial microneedle thrombolysis under microscopic visualization, in addition to standard clinical treatment for RAO. A 47G microneedle will be used to deliver thrombolytic agent intra-arterially per protocol.
Standard Clinical Care OnlyProcedure or surgery
The patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis.
| Study group | Role | What they receive |
|---|---|---|
| Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care | Experimental | The patients will receive standard pars plana vitrectomy (PPV) combined with direct intra-arterial microneedle thrombolysis under microscopic visualization, in addition to standard clinical treatment for RAO. A 47G microneedle will be used to deliver thrombolytic agent intra-arterially per protocol. Receives: Procedure: Standard Clinical Care Only |
| Standard Clinical Care Only | Active comparator | The patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis. Receives: Procedure: Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-Corrected Visual Acuity
Measured: 1 month postoperatively
Secondary outcomes (3)
Visual Field Improvement
Humphrey Perimetry
Measured: Baseline to 1 week, 1, 3, 6, and 12 months postoperatively
Retinal Reperfusion Rate
fluorescein fundus angiography
Measured: Baseline to 1 week, 1, 3, 6, and 12 months postoperatively
OCT/OCTA Structural-Perfusion Changes
Measured: Baseline to 1 week, 1, 3, 6, and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Retinal Artery OcclusionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151755
- Sponsor's protocol ID
- 20251159
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microneedle Intra-Arterial Injection With Pars Plana Vitrectomy for Acute Retinal Artery Occlusion: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07151755
- Acronym / sponsor ID
- 20251159
- Conditions
- Central Retinal Artery Occlusion
- Keywords
- central retinal artery occlusion, microneedle, thrombolysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Sep 2025 (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 prospective interventional study evaluates the efficacy and safety of direct intra-arterial microneedle injection combined with pars plana vitrectomy for acute retinal artery occlusion (including central retinal artery occlusion [CRAO] and branch retinal artery occlusion [BRAO] involving the macula or causing severe visual loss). The primary endpoint is best-corrected visual acuity (BCVA, LogMAR) at 1 month. Secondary objectives include assessing the effect of treatment timing and monitoring longitudinal changes in visual function and retinal structure over 12 months.
Detailed description
Retinal artery occlusion lacks an established standard therapy. This prospective, non-randomized, parallel-group interventional trial compares pars plana vitrectomy with direct intra-arterial microneedle thrombolysis plus standard care (experimental arm) with standard clinical care alone (control arm). The trial is open-label, and outcome assessors for BCVA, automated perimetry, fluorescein angiography (FFA), and optical coherence tomography (OCT) will be masked. Scheduled visits occur at 1 week, 1 month, 3 months, 6 months, and 12 months. The symptom-to-treatment interval (≤3 days vs 3-7 days) is a prespecified subgroup for secondary analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care | Experimental | Procedure: Standard Clinical Care OnlyThe patients will receive standard pars plana vitrectomy (PPV) combined with direct intra-arterial microneedle thrombolysis under microscopic visualization, in addition to standard clinical treatment for RAO. A 47G microneedle will be used to deliver thrombolytic agent intra-arterially per protocol. |
| Standard Clinical Care Only | Active comparator | Procedure: Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard CareThe patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Acute non-arteritic retinal artery occlusion (RAO), including: Central retinal artery occlusion (CRAO), or Branch retinal artery occlusion (BRAO) involving the macula or causing severe visual loss; defined as symptom onset ≤7 days and confirmed by exam ± imaging (FFA/OCT)
- Best-corrected visual acuity (BCVA) <0.5 (decimal)
Key exclusion criteria (10 listed)
- Active bleeding disorder, or significant bleeding within the past 3 months, or bleeding diathesis
- Severe hypertension: SBP >185 mmHg or DBP >110 mmHg
- Severe coagulopathy or ongoing therapeutic anticoagulation
- Ischemic stroke within the past 3 months
- Severe, unstable systemic disease rendering surgery or anesthesia risk unacceptable
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 |
|---|---|---|
| Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard CareThe patients will receive standard pars plana vitrectomy (PPV) combined with direct intra-arterial microneedle thrombolysis under microscopic visualization, in addition to standard clinical treatment for RAO. A 47G microneedle will be used to deliver thrombolytic agent intra-arterially per protocol. | Procedure or surgery | Standard Clinical Care Only |
| Standard Clinical Care OnlyThe patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis. | Procedure or surgery | Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care |
Primary outcome
Best-Corrected Visual Acuity
Time frame: 1 month postoperatively
3 secondary outcomes
Visual Field Improvement
Time frame: Baseline to 1 week, 1, 3, 6, and 12 months postoperatively
Retinal Reperfusion Rate
Time frame: Baseline to 1 week, 1, 3, 6, and 12 months postoperatively
OCT/OCTA Structural-Perfusion Changes
Time frame: Baseline to 1 week, 1, 3, 6, and 12 months postoperatively
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 3 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Clinical Care Only in people with Central Retinal Artery Occlusion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 3 inclusion and 10 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 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Jian Ma, MD. (+8618858299889, jian_ma@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-Corrected Visual Acuity (time frame: 1 month postoperatively). 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 3 Sep 2025.