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Safety and Efficacy After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion

Primary Purpose

Central Retinal Artery Occlusion

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intra-arterial thrombolysis
conservative treatments
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Artery Occlusion focused on measuring central retinal artery occlusion, intra-arterial thrombolysis, visual field

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Non-arteritic CRAO with symptom duration ≤7d
  2. Age from 18 years old between 80 years old
  3. 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,
  4. Meet the inclusion of HBOT

Exclusion Criteria:

  • Ocular factor or disease

    1. Branch retinal artery occlusion
    2. Combined retinal vein occlusion
    3. Suspicious ocular ischemic syndrome, such as ophthalmic artery occlusion or carotid artery occlusion
    4. Existed retinal problems decreasing visual function, such as macular disease, severe nonproliferative or proliferative diabetic retinopathy, severe cataract or glaucoma
    5. Central retinal artery occlusion from iatrogenic cause
    6. History of thrombolysis for CRAO or CRVO
  • Systemic factors restricting thrombolysis

    1. Uncontrolled hypertension (systolic blood pressure > 180mmHg ); Uncontrolled hyperglycemia (fasting blood glucose > 9mmol/L);
    2. Coagulation disorder
    3. History of intracranial hemorrhage, heart attack, cerebral infarction, or intracranial surgery within 3 mo
    4. Current antithrombotic treatment
    5. History of allergic reaction to contrast agent or rt-PA

Sites / Locations

  • Xinhua Hospital, Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

IAT combined with conservative therapies

Conservative therapies

Arm Description

IAT (Drug: 50 mg Alteplase)+conservative treatments

conservative treatments including traditional ones and hyperbaric oxygen therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of Best corrected visual acuity (BCVA) at 3 months
best corrected visual acuity of logarithm of the minimum angle of resolution
Adverse reactions at 1 month
Death, symptomatic or asymptomatic intracranial hemorrhage, intraocular hemorrhage

Full Information

First Posted
August 29, 2022
Last Updated
September 27, 2022
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05562284
Brief Title
Safety and Efficacy After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion
Official Title
Safety and Efficacy of the Visual Field Improvement After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. The respective responses of brain and retinal tissues to acute ischemia share many features is the rationale for therapeutic thrombolysis in CRAO. Intravenous thrombolysis (IVT) has been a therapeutic choice for CRAO since the 1960s, and in the United States, tPA is currently administered in 5.8% of patients admitted with CRAO. 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 which has the advantage of reducing the dose of rt-PA reaching the systemic circulation. Thus, IAT 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. Sequential evaluation by Humphrey perimetry will evaluate the temporal changes before and after IAT or conservative therapies. Our study will enroll patients within 7 days of symptom onset and aims at evaluating the safety of IAT and comparing the improvement of the VFDs between conservative treatments and IAT combined with conservative treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Artery Occlusion
Keywords
central retinal artery occlusion, intra-arterial thrombolysis, visual field

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IAT combined with conservative therapies
Arm Type
Experimental
Arm Description
IAT (Drug: 50 mg Alteplase)+conservative treatments
Arm Title
Conservative therapies
Arm Type
Other
Arm Description
conservative treatments including traditional ones and hyperbaric oxygen therapy
Intervention Type
Procedure
Intervention Name(s)
intra-arterial thrombolysis
Intervention Description
IAT introduces rt-PA directly into the ophthalmic circulation by super-selective microcatheterization.
Intervention Type
Other
Intervention Name(s)
conservative treatments
Intervention Description
conservative treatments
Primary Outcome Measure Information:
Title
Change of the visual field index as mean deviation (MD) examed by Humphrey visual field analyzer at 3 months
Description
Change of the mean deviation
Time Frame
90 days
Title
Change of the visual field index as visual field index (VFI) examed by Humphrey visual field analyzer at 3 months
Description
Change of the visual field index
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Change of Best corrected visual acuity (BCVA) at 3 months
Description
best corrected visual acuity of logarithm of the minimum angle of resolution
Time Frame
90 days
Title
Adverse reactions at 1 month
Description
Death, symptomatic or asymptomatic intracranial hemorrhage, intraocular hemorrhage
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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, Meet the inclusion of HBOT Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Fei
Phone
15000672472
Email
shirleypingfei@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Fei, MD#PhD
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Fei
Phone
15000672472
Email
shirleypingfei@126.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
protocols
IPD Sharing Time Frame
90 days after the interventions
IPD Sharing Access Criteria
if required propriately

Learn more about this trial

Safety and Efficacy After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion

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