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

Central Retinal Artery Occlusion Clinical Trial

Official title:

Safety and Efficacy of the Visual Field Improvement After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562284
• Other study ID #: XHEC-C-2022-056
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2022
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Ping Fei
• Phone: 15000672472
• Email: shirleypingfei[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Central Retinal Artery Occlusion
• Retinal Artery Occlusion

Intervention

Procedure:
• intra-arterial thrombolysis
IAT introduces rt-PA directly into the ophthalmic circulation by super-selective microcatheterization.

Other:
• conservative treatments
conservative treatments

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change of Best corrected visual acuity (BCVA) at 3 months	best corrected visual acuity of logarithm of the minimum angle of resolution	90 days
Secondary	Adverse reactions at 1 month	Death, symptomatic or asymptomatic intracranial hemorrhage, intraocular hemorrhage	30 days