UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056107 |
|---|---|
| Receipt number | R000064105 |
| Scientific Title | Multicenter Retrospective Study on Low-Dose Intravenous Alteplase for Central Retinal Artery Occlusion |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2026/05/11 09:43:01 |
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Basic information
Public title
Multicenter Retrospective Study on Low-Dose Intravenous Alteplase for Central Retinal Artery Occlusion
Acronym
Multicenter Retrospective Study on Low-Dose Intravenous Alteplase for Central Retinal Artery Occlusion
Scientific Title
Multicenter Retrospective Study on Low-Dose Intravenous Alteplase for Central Retinal Artery Occlusion
Scientific Title:Acronym
Multicenter Retrospective Study on Low-Dose Intravenous Alteplase for Central Retinal Artery Occlusion
Region
| Japan |
Condition
Condition
Non-arteritic (NA) central retinal artery occlusion (CRAO, including branch retinal artery occlusion [BRAO] predicted to have a poor visual outcome)
Classification by specialty
| Neurology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness and safety of low-dose (0.6 mg/kg) intravenous alteplase for CRAO within 4.5 hours of onset, the factors associated with visual recovery following this treatment, and the characteristics of cases in which this therapy demonstrates efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Recovery to a corrected visual acuity of 20/100 or better in the affected eye within one month of onset (or, if pre-morbid visual acuity was below 20/100, an improvement of logMAR visual acuity by 0.3 or greater from onset or improvement to pre-morbid visual acuity)
Key secondary outcomes
Efficacy secondary outcomes
Primary outcome measures for cases with initial visual acuity below 20/2000, below 20/200, and for CRAO cases
For all enrolled cases and cases with initial visual acuity below 20/2000, below 20/200, and CRAO cases: degree of improvement in logMAR visual acuity from onset, improvement of logMAR visual acuity by 0.1 or greater, improvement of logMAR visual acuity by 0.3 or greater, and shift analysis
Modified Rankin Scale (mRS) score at one month after onset
Safety outcomes
Serious bleeding events within 36 hours (symptomatic/any intracranial hemorrhage, intraocular hemorrhage, other bleeding), onset of cerebral infarction within one month, recurrence of CRAO/BRAO in the affected eye within one month, and mortality within one month
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adults aged 18 years or older
2. Patients diagnosed with NA-CRAO (or BRAO with a poor visual prognosis) by an ophthalmologist
3. Patients who presented within 24 hours of onset
4. Patients who presented between October 1, 2021 (or the date when the collaboration system between ophthalmologists and stroke physicians was established), and September 30, 2024
Key exclusion criteria
1. Patients suspected of arteritic CRAO (or BRAO)
2. Patients who showed rapid visual improvement naturally (e.g., transient monocular blindness)
3. Patients with non-endogenous mechanisms of onset (e.g., related to ophthalmic or cosmetic surgery, trauma)
4. Patients who received urgent (within 48 hours of onset) endovascular treatment or carotid revascularization therapy
5. Cases where the patient or their legal representative expressed a desire not to participate
6. Patients deemed ineligible for enrollment by the study physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Mikito |
| Middle name | |
| Last name | Hayakawa |
Organization
University of Tsukuba Hospital
Division name
Department of Stroke and Cerebrovascular Diseases
Zip code
305-8576
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
0298533220
hayakawa.mikito@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Mikito |
| Middle name | |
| Last name | Hayakawa |
Organization
University of Tsukuba Hospital
Division name
Department of Stroke and Cerebrovascular Diseases
Zip code
3058576
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
0298533220
Homepage URL
hayakawa.mikito@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Stroke and Cerebrovascular Diseases, University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Stroke and Cerebrovascular Diseases, University of Tsukuba Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Reserch & Development Organization
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
Tel
029-853-7562
rinshokenkyu@un.tsukuba.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
筑波大学附属病院（茨城県）、京都府立医科大学付属病院（京都府）、神戸市立医療センター中央市民病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
41
Results
Patients were analysed if they had best-corrected visual acuity below 10/200, clearly defined symptom onset, absence of proliferative retinopathy, and 30-day visual outcome data. Sixteen of 41 registered patients were analysed (9 received IVT). The primary outcome was achieved in 22.2% of the IVT group versus 0% of the non-IVT group. Improvement in logMAR was greater in the IVT group (median difference 0.45 [95%CI, 0.18 to 1.20]; p=0.023).
Results date posted
| 2026 | Year | 05 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mean age, 70.1 (12.6) years; 4 were women (25%); 13 had CRAO (81.3%).
Participant flow
Among 41 registered patients, 16 patients were analysed if they had best-corrected visual acuity < 10/200, clearly defined symptom onset, absence of proliferative retinopathy, and 30-day visual outcome data.
Adverse events
One asymptomatic intracranial hemorrhage occured
Outcome measures
The primary outcome was 30-day BCVA 20/100 or above; secondary outcome included change in BCVA (logarithm of the minimum angle of resolution [logMAR]); and safety outcomes included intracranial hemorrhage (ICH).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2024 | Year | 11 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064105
