Microneedle intra-arterial injection plus vitrectomy for acute retinal artery occlusion
Official title: Microneedle Intra-Arterial Injection With Pars Plana Vitrectomy for Acute Retinal Artery Occlusion: A Prospective Clinical Trial
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT07151755 · Data updated 2026-11-12
This trial will try a microneedle intra-arterial thrombolytic injection combined with vitrectomy to restore vision in adults with acute central retinal artery occlusion or macula-involving branch retinal artery occlusion within 7 days of symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | September 3, 2025 |
| Trial ID | NCT07151755 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with acute non-arteritic central retinal artery occlusion or macula-involving branch retinal artery occlusion confirmed within 7 days of symptom onset and with best-corrected visual acuity worse than 0.5 (decimal) are eligible.
✕Probably not a fit
Patients with arteritic RAO, active bleeding disorders, recent ischemic stroke, severe uncontrolled hypertension, ongoing therapeutic anticoagulation, vitreous hemorrhage, pregnancy or lactation, or symptom onset beyond 7 days are unlikely to benefit or are ineligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, non-randomized, open-label interventional trial comparing pars plana vitrectomy with direct intra-arterial microneedle thrombolysis plus standard care versus standard clinical care alone for acute non-arteritic retinal artery occlusion. Outcome assessors for visual acuity, visual fields, fluorescein angiography, and OCT are masked to treatment allocation. The primary outcome is best-corrected visual acuity (LogMAR) at 1 month, with additional follow-up visits at 1 week, 3 months, 6 months, and 12 months to monitor structural and functional changes. A prespecified subgroup analysis will compare outcomes based on symptom-to-treatment interval (≤3 days vs 3–7 days).
Why it matters
Potential benefit: If successful, the procedure could improve restoration of retinal blood flow and lead to better short- and long-term visual outcomes compared with standard care.
How similar studies have gone: Prior case reports and small series of intra-arterial thrombolysis and vitrectomy for retinal artery occlusion have shown mixed and limited results, so the combined microneedle approach remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Eye Center of the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Jian Ma, MD.
- Email: jian_ma@zju.edu.cn
- Phone: +8618858299889
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.