NCT07151755 Microneedle Intra-Arterial Injection for Retinal Artery Occlusion
| NCT ID | NCT07151755 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Central Retinal Artery Occlusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-09-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Active ocular infection * Vitreous hemorrhage * Retinal arteritis * Pregnancy or lactation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07151755 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Central Retinal Artery Occlusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07151755 currently recruiting?
Yes, NCT07151755 is actively recruiting participants. Contact the research team at jian_ma@zju.edu.cn for enrollment information.
Where is the NCT07151755 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07151755 clinical trial?
NCT07151755 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 24 participants.