NCT05562284

Brief Summary

Central retinal artery occlusion (CRAO) is an ophthalmic emergency which leads to devastating visual function defects and poor prognosis. Though traditional conservative treatments are widely used, none of them is proved to be effective. A number of meta-analyses and observational studies indicate intravenous thrombolysis to be beneficial in CRAO. Selective intra-arterial thrombolysis (IAT) introducing rt-PA directly into the ophthalmic circulation by super-selective microcatheterization may reduce the complications such as intracranial and systemic hemorrhage.The residual visual field is significant for patients with CRAO who have poor central visual acuity. Thus, it is clinically significant to study the changes in visual fields in eyes with CRAO.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

1.8 years

First QC Date

August 29, 2022

Last Update Submit

September 27, 2022

Conditions

Central Retinal Artery Occlusion

Keywords

central retinal artery occlusionintra-arterial thrombolysisvisual field

Outcome Measures

Primary Outcomes (2)

  • Change of the visual field index as mean deviation (MD) examed by Humphrey visual field analyzer at 3 months

    Change of the mean deviation

    90 days

  • Change of the visual field index as visual field index (VFI) examed by Humphrey visual field analyzer at 3 months

    Change of the visual field index

    90 days

Secondary Outcomes (2)

  • Change of Best corrected visual acuity (BCVA) at 3 months

    90 days

  • Adverse reactions at 1 month

    30 days

Study Arms (2)

IAT combined with conservative therapies

EXPERIMENTAL

IAT (Drug: 50 mg Alteplase)+conservative treatments

Procedure: intra-arterial thrombolysisOther: conservative treatments

Conservative therapies

OTHER

conservative treatments including traditional ones and hyperbaric oxygen therapy

Other: conservative treatments

Interventions

intra-arterial thrombolysisPROCEDURE

IAT introduces rt-PA directly into the ophthalmic circulation by super-selective microcatheterization.

IAT combined with conservative therapies
conservative treatmentsOTHER

conservative treatments

Conservative therapiesIAT combined with conservative therapies

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-arteritic CRAO with symptom duration ≤7d
  • Age from 18 years old between 80 years old
  • Qualified systemic conditions, well-controlled blood pressure, well-controlled blood glucose, qualified liver and kidney function, no allergic history to contrast agent or rt-PA,

You may not qualify if:

  • Ocular factor or disease
  • Branch retinal artery occlusion
  • Combined retinal vein occlusion
  • Suspicious ocular ischemic syndrome, such as ophthalmic artery occlusion or carotid artery occlusion
  • Existed retinal problems decreasing visual function, such as macular disease, severe nonproliferative or proliferative diabetic retinopathy, severe cataract or glaucoma
  • Central retinal artery occlusion from iatrogenic cause
  • History of thrombolysis for CRAO or CRVO
  • Systemic factors restricting thrombolysis
  • Uncontrolled hypertension (systolic blood pressure \> 180mmHg ); Uncontrolled hyperglycemia (fasting blood glucose \> 9mmol/L);
  • Coagulation disorder
  • History of intracranial hemorrhage, heart attack, cerebral infarction, or intracranial surgery within 3 mo
  • Current antithrombotic treatment
  • History of allergic reaction to contrast agent or rt-PA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200092, China

RECRUITING

MeSH Terms

Conditions

Retinal Artery Occlusion

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Ping Fei, MD#PhD

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Fei

CONTACT

15000672472shirleypingfei@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 29, 2022

First Posted

September 30, 2022

Study Start

June 1, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

protocols

Shared Documents
STUDY PROTOCOL
Time Frame
90 days after the interventions
Access Criteria
if required propriately

Locations

CN(1)