Microneedle intra-arterial injection plus vitrectomy for acute retinal artery occlusion

Microneedle Intra-Arterial Injection With Pars Plana Vitrectomy for Acute Retinal Artery Occlusion: A Prospective Clinical Trial

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

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07151755 on ClinicalTrials.gov

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).

Who should consider this trial

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.

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.

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 performed: 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.

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

Where this trial is running

Hangzhou, Zhejiang

• Eye Center of the Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Jian Ma, MD.

Conditions: Central Retinal Artery Occlusion, central retinal artery occlusion, microneedle, thrombolysis