Microneedle Intra-Arterial Injection for Retinal Artery Occlusion

NCT ID: NCT07151755

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-07-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Standard Clinical Care Only

Intervention Type: PROCEDURE

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

Standard Clinical Care Only

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

Group Type: ACTIVE_COMPARATOR

Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Standard Clinical Care Only

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eye Center of the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian Ma, MD.

Role: CONTACT

jian_ma@zju.edu.cn

+8618858299889

Facility Contacts

Jian Ma, MD.

Role: primary

jian_ma@zju.edu.cn

+8618858299889

Other Identifiers

20251159

Identifier Type: -

Identifier Source: org_study_id