NCT07151755

Microneedle Intra-Arterial Injection for Retinal Artery Occlusion

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Central Retinal Artery Occlusion

Interventions

Type	Name	Description
PROCEDURE	Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care	The patients will receive standard pars plana vitrectomy (PPV) combined with direct intra-arterial microneedle thrombolysis under microscopic visualization, in addition to standard clinical treatment for RAO. A 47G microneedle will be used to deliver thrombolytic agent intra-arterially per protocol.
PROCEDURE	Standard Clinical Care Only	The patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2025-09-03
• Last updated: 2025-09-03

Locations

1 site across 1 country: China