Microneedle Intra-Arterial Injection for Retinal Artery Occlusion

Zhejiang University

Status: Enrolling

Conditions: Central Retinal Artery Occlusion

Treatments: Procedure: Standard Clinical Care Only; Procedure: Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07151755

20251159

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care

Experimental group

Description:

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.

Treatment:

Procedure: Standard Clinical Care Only

Standard Clinical Care Only

Active Comparator group

Description:

The patients will receive standard clinical treatment for RAO without vitrectomy or intra-arterial microneedle thrombolysis.

Treatment:

Procedure: Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care