Health TrialsbyHealthPanel

Microneedle Intra-Arterial Injection for Retinal Artery Occlusion

ConditionCentral Retinal Artery Occlusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard Care

    Procedure/Surgery

    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

    Procedure/Surgery

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

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Vitrectomy + Direct Intra-Arterial Microneedle Thrombolysis + Standard CareExperimental treatment 1 intervention
Group B: Standard Clinical Care OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Best-Corrected Visual Acuity

Time frame
1 month postoperatively

Secondary outcomes

1

Visual Field Improvement

Humphrey Perimetry

Time frame
Baseline to 1 week, 1, 3, 6, and 12 months postoperatively
2

Retinal Reperfusion Rate

fluorescein fundus angiography

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

OCT/OCTA Structural-Perfusion Changes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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