UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001546 |
|---|---|
| Receipt number | R000001860 |
| Scientific Title | Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on macular edema secondary to branch retinal vein occlusion |
| Date of disclosure of the study information | 2008/12/02 |
| Last modified on | 2024/06/25 00:18:49 |
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Basic information
Public title
Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on macular edema secondary to branch retinal vein occlusion
Acronym
Comparative study of Be and TA on BRVO
Scientific Title
Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on macular edema secondary to branch retinal vein occlusion
Scientific Title:Acronym
Comparative study of Be and TA on BRVO
Region
| Japan |
Condition
Condition
Macular edema secondary to branch retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of an intravitral injection of bevacizumab with that of triamcinolone acetonide for macular edema secondary to branch retinal vein occlusion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
variation on a logarithm of the minimum angle of resolution and variation on a central retinal thickness 1 month, 3 months, 6 months, 9 months, and 12 months after intravitreal injection.
Key secondary outcomes
fluorescin angiography before and 1 month, 3 months, 6 months, 9 months, and 12 months after intravitreal injection.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
duration: 12 months
quantity: bevacizumab 1.25 mg
number: no addition injection 3 months after primary injection and addition injection if the visual acuity decrease or the central retinal thicknes increase more than 100 micro meter.
Interventions/Control_2
duration: 12 months
quantity: triamcinolone acetonide 20 mg
number: no addition injection 3 months after primary injection and addition injection if the visual acuity decrease or the central retinal thicknes increase more than 100 micro meter.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
visual acuity less than 0.5
central retinal thickness more than 300 micro meter
Key exclusion criteria
glaucoma
ocular pressure more than 21 mmHg
inflammation disease
diabetic retinopathy
history of steroid therapy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Ohji |
Organization
Shiga University of Medical Science
Division name
department of Ophthalmology
Zip code
5202192
Address
Seta Tukinowacho, Otsu, Shiga
TEL
077-548-2276
osawada@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Sawada |
Organization
Shiga University of Medical Science
Division name
department of Ophthalmology
Zip code
5202142
Address
Seta Tukinowacho, Otsu, Shiga
TEL
077-548-2276
Homepage URL
http://www.shiga-med.ac.jp/
l-eye@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology of Japan and Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta Tsukinowacho, Otsu, Shiga 5202192
Tel
077-548-3576
hqrec@belle.shiga-med.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
滋賀医科大学医学部附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/j.1755-3768.2009.01717.x
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/j.1755-3768.2009.01717.x
Number of participants that the trial has enrolled
43
Results
Eighteen eyes in 18 patients in the triamcinolone acetonide intravitreal injection (IVTA) group and 18 eyes in 18 patients in the bevacizumab intravitreal injection (IVB) group were followed for 12 months. The mean improvement in corrected visual acuity from baseline to 12 months was 0.12 in the IVTA group and 0.33 in the IVB group, significantly greater in the IVB group. The mean reduction in central retinal thickness from baseline to 12 months was not significantly different between the two groups.
Results date posted
| 2024 | Year | 06 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2011 | Year | 07 | Month | 14 | Day |
Baseline Characteristics
The IVTA group included 15 women and 6 men, with a mean age of 70.4 (range, 53-88) years, mean disease duration to first injection of 100.1 (range, 23-227) days, mean baseline logMAR best corrected visual acuity of 0.62 (range, 0.30-1.10) The mean baseline central retinal thickness was 521 microns (range, 338-828 microns) in the 10 eyes measured by Stratus OCT and 719 microns (range, 442-1088 microns) in the 11 eyes measured by Cirrus OCT.
The IVB group included 11 women and 11 men, with a mean age of 66.5 (range, 49-81) years, mean disease duration to first injection of 95.0 (range, 27-224) days, and mean baseline logMAR best corrected visual acuity of 0.58 (range, 0.30-1.05). The mean baseline central retinal thickness was 525 microns (range, 349-624 microns) in the 11 eyes measured by Stratus OCT and 699 microns (range, 378-1240 microns) in the 11 eyes measured by Cirrus OCT.
There were no significant differences between the two groups in baseline gender, age, best corrected visual acuity, or central retinal thickness.
Eight patients in the IVTA group had a history of hypertension and nine patients in the IVB group had a history of hypertension.
Participant flow
In the IVTA group, 18 eyes of 18 patients completed the 12-month follow-up, and 3 patients dropped out: 1st patient stopped coming at 4 months; 2nd patient dropped out at 6 months due to IOP elevation after the initial injection and treatment to lower IOP; 3rd patient dropped out at 9 months due to vitreous hemorrhage after the second injection.
In the IVB group, 18 eyes of 18 patients completed the 12-month follow-up, and 4 patients dropped out. 4 patients dropped out because they did not come to the hospital at 4, 6, 9, or 12 months.
Adverse events
In the IVTA group, four eyes had elevated IOP of 21 mmHg or higher; two of the four eyes with IOPs of 21 mmHg and 23 mmHg returned to normal without treatment at the next visit; one eye with an elevated IOP of 28 mmHg was treated with medication and the IOP normalized; the other whose IOP rose to 41 mmHg after the first injection required a trabeculectomy. One eye in the IVTA group developed vitreous hemorrhage after the second injection.
In the IVB group, two eyes had elevated IOP of 21 mmHg or higher; two eyes with IOPs of 21 mmHg and 22 mmHg returned to normal without treatment at the next visit.
Outcome measures
#LogMAR BCVA
In the IVTA group, logMAR BCVA significantly improved from a mean of 0.58 at baseline to a mean of 0.46 at month 12 in the 18 eyes followed for 12 months.
In the IVB group, logMAR BCVA significantly improved from a mean of 0.58 at baseline to a mean of 0.25 at month 12 in the 18 eyes followed for 12 months.
The change in logMAR BCVA from baseline to month 12 was 0.12 in the IVTA group and 0.33 in the IVB group, with the change being significantly greater in the IVB group.
The percentage of patients with a change in LogMAR BCVA of 0.3 or greater from baseline to month 12 was significantly greater in the IVB group, 22% in the IVTA group and 67% in the IVB group.
#Central retinal thickness (CRT)
In the IVTA group, CRT significantly improved from a mean of 520 microns at baseline to a mean of 216 microns at 12 months in the 9 eyes measured with Stratus OCT and from a mean of 679 microns at baseline to a mean of 372 microns at 12 months in the 9 eyes measured with Cirrus OCT, out of 18 eyes followed at 12 months.
In the IVB group, CRT significantly improved from a mean of 553 microns at baseline to a mean of 282 microns at month 12 in 8 of 18 eyes measured with Stratus OCT and from a mean of 708 microns at baseline to a mean of 346 microns at month 12 in 10 eyes measured with Cirrus OCT, out of a possible 18 eyes followed at 12 months.
The mean improvements in CRT from baseline to month 12 were 340 microns in the IVTA group and 270 microns in the IVB group in eyes measured by Stratus OCT; in eyes measured by Cirrus OCT, they were 306 microns in the IVTA group and 362 microns in the IVB group. There was no significant difference in CRT improvement between the two groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2009 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 02 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001860
