NCT07151755

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Sep 2025Jul 2027

First Submitted

Initial submission to the registry

August 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

August 25, 2025

Last Update Submit

August 25, 2025

Conditions

Central Retinal Artery Occlusion

Keywords

central retinal artery occlusionmicroneedlethrombolysis

Outcome Measures

Primary Outcomes (1)

  • Best-Corrected Visual Acuity

    1 month postoperatively

Secondary Outcomes (3)

  • Visual Field Improvement

    Baseline to 1 week, 1, 3, 6, and 12 months postoperatively

  • Retinal Reperfusion Rate

    Baseline to 1 week, 1, 3, 6, and 12 months postoperatively

  • OCT/OCTA Structural-Perfusion Changes

    Baseline to 1 week, 1, 3, 6, and 12 months postoperatively

Study Arms (2)

Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care

EXPERIMENTAL

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

Standard Clinical Care Only

ACTIVE COMPARATOR

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

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

Interventions

Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard CarePROCEDURE

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.

Standard Clinical Care Only
Standard Clinical Care OnlyPROCEDURE

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

Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Center of the Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310058, China

RECRUITING

MeSH Terms

Conditions

Retinal Artery Occlusion

Interventions

VitrectomyStandard of Care

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, OperativeQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Jian Ma, MD.

CONTACT

+8618858299889jian_ma@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 3, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)