Central Retinal Artery OcclusionNCT05562284
Safety and Efficacy After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion
A study testing intra-arterial thrombolysis and conservative treatments in people with Central Retinal Artery Occlusion, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Retinal Artery Occlusion
- What is being tested?
- intra-arterial thrombolysis and conservative treatments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Ping Fei, 15000672472, shirleypingfei@126.com
About this study
Official title: Safety and Efficacy of the Visual Field Improvement After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion
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.
Read the 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
- Being tested
- intra-arterial thrombolysis, conservative treatments
- Keywords
- central retinal artery occlusion, intra-arterial thrombolysis, visual field
- Medical subject headings
- Retinal Artery Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-arterial thrombolysisProcedure or surgery
IAT introduces rt-PA directly into the ophthalmic circulation by super-selective microcatheterization.
conservative treatmentsOther
conservative treatments
| Study group | Role | What they receive |
|---|---|---|
| IAT combined with conservative therapies | Experimental | IAT (Drug: 50 mg Alteplase)+conservative treatments Receives: Procedure: intra-arterial thrombolysis; Other: conservative treatments |
| Conservative therapies | Other | conservative treatments including traditional ones and hyperbaric oxygen therapy Receives: Other: conservative treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the visual field index as mean deviation (MD) examed by Humphrey visual field analyzer at 3 months
Change of the mean deviation
Measured: 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
Measured: 90 days
Secondary outcomes (2)
Change of Best corrected visual acuity (BCVA) at 3 months
best corrected visual acuity of logarithm of the minimum angle of resolution
Measured: 90 days
Adverse reactions at 1 month
Death, symptomatic or asymptomatic intracranial hemorrhage, intraocular hemorrhage
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Jun 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Retinal Artery OcclusionStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Fei, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Ping Fei, MD#PhD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562284
- Sponsor's protocol ID
- XHEC-C-2022-056
- Status last verified
- Sep 2022
- First submitted
- 29 Aug 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: protocols
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Visual Field Improvement After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion
- ClinicalTrials.gov ID
- NCT05562284
- Acronym / sponsor ID
- XHEC-C-2022-056
- Conditions
- Central Retinal Artery Occlusion
- Keywords
- central retinal artery occlusion, intra-arterial thrombolysis, visual field
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IAT combined with conservative therapies | Experimental | Procedure: intra-arterial thrombolysis, Other: conservative treatmentsIAT (Drug: 50 mg Alteplase)+conservative treatments |
| Conservative therapies | Other | Other: conservative treatmentsconservative treatments including traditional ones and hyperbaric oxygen therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Ocular factor or disease
- Systemic factors restricting thrombolysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-arterial thrombolysisIAT introduces rt-PA directly into the ophthalmic circulation by super-selective microcatheterization. | Procedure or surgery | IAT combined with conservative therapies |
| conservative treatmentsconservative treatments | Other | Conservative therapies, IAT combined with conservative therapies |
Primary outcome
Change of the visual field index as mean deviation (MD) examed by Humphrey visual field analyzer at 3 months
Time frame: 90 days
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
Time frame: 90 days
Change of the visual field index
2 secondary outcomes
Change of Best corrected visual acuity (BCVA) at 3 months
Time frame: 90 days
Adverse reactions at 1 month
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: Yes. protocols
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Fei, MD#PhD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-arterial thrombolysis and conservative treatments in people with Central Retinal Artery Occlusion, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Fei (15000672472, shirleypingfei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the visual field index as mean deviation (MD) examed by Humphrey visual field analyzer at 3 months (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.