UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Various visual functions and vision-related quality of life in patients with macular edema secondary to retinal vein occlusion following intravitreal ranibizumab injection.
Title of the study (Brief title)	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	Fumiki Okamoto
Organization	University of Tsukuba
Division name	Department of Ophthalmology, Faculty of Medicin
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	Fumiki Okamoto
Organization	University of Tsukuba
Division name	Department of Ophthalmology, Faculty of Medicin
Address	1-1-1 Tennoudai, Tsukuba, Ibaraki, 305-8575 Japa
TEL	029-853-3148
Homepage URL
Email	fumiki-o@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023473