Microneedle Intra-Arterial Injection for Retinal Artery Occlusion

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.

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