UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036698 |
|---|---|
| Receipt number | R000041813 |
| Scientific Title | Pathophysiology and visual prognosis of cases with submacular hemorrhage: multicenter retrospective observational study |
| Date of disclosure of the study information | 2019/05/10 |
| Last modified on | 2023/06/22 21:31:35 |
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Basic information
Public title
Pathophysiology and visual prognosis of cases with submacular hemorrhage: multicenter retrospective observational study
Acronym
Retrospective observational study of cases with submacular hemorrhage
Scientific Title
Pathophysiology and visual prognosis of cases with submacular hemorrhage: multicenter retrospective observational study
Scientific Title:Acronym
Retrospective observational study of cases with submacular hemorrhage
Region
| Japan |
Condition
Condition
Submacular hemorrhage associated with wet age related macular degeneration, retinal macroaneurysm or any other disease.
Classification by specialty
| Infectious disease | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In wet age-related macular degeneration involving the fovea, intravitreous administration of vascular endothelial growth factor (VEGF) inhibitors and the usefulness of photodynamic therapy (PDT) has been demonstrated. However, during the course of treatment there may be extensive submacular hemorrhage or hemorrhagic retinal pigment epithelial detachment even during treatment, and there is no established treatment for submacular hemorrhage and the treatment content is case or it depends on the facility. We will conduct observational research on various clinical findings and treatment options at the time of hemorrhage and prognosis in cases with severe submacular hemorrhage. At the same time, it is also examined whether the disease duration, treatment, presence of retinal pigment epithelial detachment may affect the prognosis after hemorrhage. This is expected to provideuseful information leading to the selection of an appropriate medical care policy and treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Best corrected visual acuity (BCVA) and change of BCVA
Key secondary outcomes
Findings as fundus and optical coherence tomography at and after hemorrhage
Pathology and treatment history before bleeding in age related macular degeneration
Kind of treatment and its effect
Association with systemic complications and oral administration
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subretinal hemorrhage between April 2015 and September 2018
2) Subretinal hemorrhage including the fovea more than 2 disc area
3) Ophthalmic imaging findings such as fundus photography, optical coherence tomography (optical coherence tomography angiography, fundus autofluorescence) can be obtained
4) More than 3 months have been observed after onset of subretinal hemorrhage
Key exclusion criteria
Cases in which the affected eye has a complication of retinal detachment, diabetes retinopathy, retinal vein occlusion, uveitis and other retinal vitreous diseases.
Cases that do not agree to provide data.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Yasukawa |
Organization
Nagoya City University Graduate School of Medical Sciences.
Division name
Department of Ophthalmology and Visual Science
Zip code
467-8601
Address
1 Kawasumi, Mizuho, Nagoya, Japan
TEL
052-853-8251
yasukawa@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Kato |
Organization
Nagoya City University Graduate School of Medical Sciences.
Division name
Department of Ophthalmology and Visual Science
Zip code
467-8601
Address
1 Kawasumi, Mizuho, Nagoya, Japan
TEL
052-853-8251
Homepage URL
akikato@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences.
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Clinical research management center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
052-858-7215
ctmc@med.nagoya-cu.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35862313/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35862313/
Number of participants that the trial has enrolled
127
Results
Sixty-seven percent of the patients were treatment naive.
Thirty-six eyes (28%) had undergone vitrectomy, 49 eyes (39%) had undergone gas pneumatic displacement, and 42 eyes (33%) had undergone anti-VEGF monotherapy.
With pneumatic displacement and vitrectomy, SRH decreased to within 1 papillary diameter in more than 40% of postoperative cases.
Final mean visual acuity (decimal unit) significantly improved from 0.13 to 0.23 and from 0.07 to 0.18, respectively.
Results date posted
| 2021 | Year | 08 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with neovascular age-related macular degeneration : 127 eyes of 127 patients (88 men and 39 women)
Participant flow
Patients with neovascular age-related macular degeneration
Greatest linear dimension of submacular hemorrhage more than 2 disc diameters and subfoveal involvement
Follow-up for more than 2 months
Adverse events
none
Outcome measures
AMD subtype
Treatment history and disease duration
Treatment chosen for SMH
Anatomical impacts of intervention on SMH
Change of best-corrected visual acuity (BCVA)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment of participants has already finished for retrospective observational examination.
Management information
Registered date
| 2019 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041813
