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
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
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
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
NCT ID
NCT05562284
First Posted
August 29, 2022
Last Updated
September 27, 2022
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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
We'll reach out to this number within 24 hrs