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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name