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Microneedle Intra-Arterial Injection for Retinal Artery Occlusion

RecruitingNAAges 18 Years - anyAllSecond Affiliated Hospital, Zhejiang University, …
NCT07151755 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care
  • Standard Clinical Care Only
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Where

1 site
Eye Center of the Second Affiliated Hospital of Zhejiang University
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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