UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020326 |
|---|---|
| Receipt number | R000023473 |
| Scientific Title | Various visual functions and vision-related quality of life in patients with macular edema secondary to retinal vein occlusion following intravitreal ranibizumab injection. |
| Date of disclosure of the study information | 2016/03/08 |
| Last modified on | 2018/12/26 15:01:37 |
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Basic information
Public title
Various visual functions and vision-related quality of life in patients with macular edema secondary to retinal vein occlusion following intravitreal ranibizumab injection.
Acronym
Various visual functions and vision-related quality of life in patients with macular edema secondary to retinal vein occlusion following intravitreal ranibizumab injection.
Scientific Title
Various visual functions and vision-related quality of life in patients with macular edema secondary to retinal vein occlusion following intravitreal ranibizumab injection.
Scientific Title:Acronym
Various visual functions and vision-related quality of life in patients with macular edema secondary to retinal vein occlusion following intravitreal ranibizumab injection.
Region
| Japan |
Condition
Condition
Macular edema secondary to retinal vein occlusion (RVO)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in visual functions, especially, change in metamorphopsia score using M-charts following intravitreal ranibizumab injection in RVO
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean change in horizontal and vertical metamorphopsia scores using M-charts from baseline at Month 12.
Key secondary outcomes
Mean change in BCVA from baseline at Month 12
Mean change in contrast sensitivity from baseline at Month 12
Mean change in central macular thickness (CRT) from baseline at Month 12
Presence/absence of inner retinal cyst over time until Month 12
Mean change in thickness of inner retinal layer from baseline at Month 12
Mean change in VR-QOL (subscale and composite scores in NEI VFQ-25) at Month 0,3,6 and 12
Adverse events (AEs) and Serious adverse events (SAEs)
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Center-involving macular edema secondary to BRVO or CRVO
2) Central Retinal Thickness (CRT) more than 250
3) Patient age of 18 years or more
Key exclusion criteria
1) Previous history of vitreoretinal surgery
2) Previous history of ophthalmic disorders except mild refractive errors and mild cataract
3) Within 90 days of macular edema treatment [ including sub-Tenon triamcinolone acetonide (STTA), intravitreal bevacizumab (IVB), intravitreal ranibizumab (IVR), intravitreal aflibercept (IVA), topical steroid, carbonic anhydrase inhibitors (CAI) ]
4) Within 90 days of intraocular surgery
5) Contralateral eye of RVO
6) Poor control of hypertension (HT) and diabetic mellitus (DM)
7) Within 30 days of laser treatment
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiki Okamoto |
Organization
University of Tsukuba
Division name
Department of Ophthalmology, Faculty of Medicin
Zip code
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japa
TEL
029-853-3148
fumiki-o@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiki Okamoto |
Organization
University of Tsukuba
Division name
Department of Ophthalmology, Faculty of Medicin
Zip code
Address
1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japa
TEL
029-853-3148
Homepage URL
fumiki-o@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 05 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 05 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 01 | Day |
Other
Other related information
Multicenter study (single group, non-controlled, non-randomized, open-label study)
Start of subject enrolment: April 2016
End of subject enrolment: DEC 2018
For patients with BRVO-CME treatment with intravitreous bevacizumab injection, we measured visual functions, retinal microstructure and QOL as follows:
Visual acuity (Month 0,1,2,3,4,5,6,7,8,9,10,11,12)
OCT measurement (Month 0,1,2,3,4,5,6,7,8,9,10,11,12)
Metamorphopsia measurement (Month 0,1,2,3,4,5,6,7,8,9,10,11,12)
Contrast sensitivity (Month 0,3,6,12)
Vision-related QOL questionnaire (Month 0,3,6,12)
Management information
Registered date
| 2015 | Year | 12 | Month | 24 | Day |
Last modified on
| 2018 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023473
