UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014964 |
|---|---|
| Receipt number | R000017420 |
| Scientific Title | Clinical study on the effect of antibacterial eye drops during administration of anti-VEGF drugs |
| Date of disclosure of the study information | 2014/08/27 |
| Last modified on | 2024/05/28 17:56:20 |
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Basic information
Public title
Clinical study on the effect of antibacterial eye drops during administration of anti-VEGF drugs
Acronym
Study on the Effectiveness of Antimicrobial Eye Drops During Anti-VEGF Drug Administration
Scientific Title
Clinical study on the effect of antibacterial eye drops during administration of anti-VEGF drugs
Scientific Title:Acronym
Study on the Effectiveness of Antimicrobial Eye Drops During Anti-VEGF Drug Administration
Region
| Japan |
Condition
Condition
AMD and RVO
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of topical antibiotics for disinfection after intravitreal injection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disinfection rate and drug sensitivity (0 month, 2 month, 3 month and 6 month)
Changes in disinfection rate and drug sensitivity (0 month, 2 month, 3 month and 6 month)
Incidence of postoperative endophthalmitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
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
Levofloxacin eye drop 1.5%
Interventions/Control_2
Levofloxacin eye drop 1.5% and Cefmenoxime hydrochloride eye drop 0.5% in turn
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients scheduled for intravitreal injection consecutive 3 times every 1 month
2)20 years of age or more
Key exclusion criteria
1)Patients with history of hypersensitivity or severe side effects on drugs using this study
2)Patients with history of intravitreal injection
3)Patients with history of antibiotics treatment within 3 months
4)Patients with history of ocular surgery within 6 months
5)Patients with heavy immune deficiency, atopic dermatitis, and diabetes
6)Patients with lacrimal duct obstruction
7)Patients whom investigators estimate are not eligible
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Wakabayashi |
Organization
Tokyo medical university hospital
Division name
Department of ophthalmology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku, Tokyo
TEL
03-3342-6111
wbaki@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Wakabayashi |
Organization
Tokyo medical university hospital
Division name
Department of ophthalmology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku, Tokyo
TEL
03-3342-6111
Homepage URL
wbaki@tokyo-med.ac.jp
Sponsor or person
Institute
Department of ophthalmology,Tokyo medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Santen pharmaceutical company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Medical Ethics Committee
Address
6-1-1 Shinjuku, Shinjuku, Tokyo
Tel
03-3351-6141
d-somu@tokyo-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
東京医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 27 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
http://journal.nichigan.or.jp/Disp?style=abst&vol=123&year=2019&mag=0&number=4&start=395
Number of participants that the trial has enrolled
38
Results
The reduction rates of bacteria after eye drops before the first injection and after the third injection were 75.0% and 53.8% in the LVFX alone group, and 72.7% and 72.7% in the cycling therapy group, respectively, but there was no statistically significant difference between the two groups. The mean MIC of LVFX against Staphylococcus epidermidis before the first injection and at the next visit after the third injection during the induction period increased significantly in both groups.
Results date posted
| 2024 | Year | 05 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
Refer to paper
Participant flow
Refer to paper
Adverse events
(Right eye) Ischemic optic neuropathy
Serious (disability)
Causal relationship to the study: Possibly related (since there have been several reports of ischemic side effects of Eylea Intravitreal Injection 40 mg/mL).
(Since there are several reports of ischemic side effects of Eylea Intravitreal Injection 40 mg/mL, the direct cause of this event may have been caused by Eylea used for the treatment of CRVO. The event was not considered to be associated with the use of Cravit ophthalmic solution 1.5%, and no causal relationship with this drug was determined.)
Cerebral infarction
Serious (cases requiring hospitalization for treatment or prolonged hospitalization)
Causal relationship with the study: May be relevant (causal relationship between cerebral infarction and Eylea Intravitreal Injection Solution 40 mg/mL)
The study concluded that a causal relationship between cerebral infarction and Eylea Intravitreal Injection 40 mg/mL could not be ruled out because the patient developed the disease after the injection. The event was not considered to be associated with the use of Cravit ophthalmic solution 1.5%, and no causal relationship with this drug was determined.)
Outcome measures
Trends in the rate of sterilization, drug sensitivity, sterilization rate and drug sensitivity at 0, 2, 3, and 6 months will be examined, and the incidence of endophthalmitis will also be evaluated.
Plan to share IPD
The dataset is not publicly available.
IPD sharing Plan description
The dataset is not publicly available.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 27 | Day |
Last modified on
| 2024 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017420
