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

NCT ID: NCT05562284

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-03-31

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.

Conditions

Central Retinal Artery Occlusion

Keywords

central retinal artery occlusion; intra-arterial thrombolysis; visual field

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IAT combined with conservative therapies

IAT (Drug: 50 mg Alteplase)+conservative treatments

Group Type: EXPERIMENTAL

intra-arterial thrombolysis

Intervention Type: PROCEDURE

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

conservative treatments

Intervention Type: OTHER

conservative treatments

Conservative therapies

conservative treatments including traditional ones and hyperbaric oxygen therapy

Group Type: OTHER

conservative treatments

Intervention Type: OTHER

conservative treatments

Interventions

intra-arterial thrombolysis

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

Intervention Type: PROCEDURE

conservative treatments

conservative treatments

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ping Fei

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ping Fei, MD#PhD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ping Fei

Role: CONTACT

Phone: 15000672472

Email: shirleypingfei@126.com

Facility Contacts

Ping Fei

Role: primary

Other Identifiers

XHEC-C-2022-056

Identifier Type: -

Identifier Source: org_study_id