UMIN-CTR Clinical Trial

Basic information
Public title	Early anti-VEGF Therapy Intervention for Retinal Vein Occlusion
Acronym	Early anti-VEGF Therapy Intervention for RVO
Scientific Title	Early anti-VEGF Therapy Intervention for Retinal Vein Occlusion
Scientific Title:Acronym	Early anti-VEGF Therapy Intervention for RVO
Region	Japan

Condition
Condition	Retinal vein occlusion
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess efficacy of early anti-VEGF intervention for retinal vein occlusion
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Mean change from baseline best corrected visual acuity and macular retinal sensitivity at month 12.
Key secondary outcomes	Mean number of intravitreal injection at month 12. Mean change from baseline central retinal thickness (CRT) at month 12. Mean change from baseline best corrected visual acuity and macular retinal sensitivity at month 6. ocular serious adverse event.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Symptomatic retinal vein occlusion with best corrected visual acuity of 20/40 or better, at least 3 months before enrollment.
Key exclusion criteria	1. prior laser treatment, surgery, local steroid injection or anti-VEGF drug administration 2. bilateral retinal vein occlusion 3. uncontrolled glaucoma 4. uncontrolled systemic hypertension 5. other retinal disorders
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kentaro Kojima
Organization	Kyoto Prefectural University of Medicine
Division name	Ophthalmology
Zip code
Address	465 kajii-cho, Kamigyo-ku, Kyoto
TEL	075-251-5578
Email	kenkojim@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kentaro Kojima
Organization	Kyoto Prefectural University of Medicine
Division name	Ophthalmology
Zip code
Address	465 kajii-cho, Kamigyo-ku, Kyoto
TEL	075-251-5578
Homepage URL
Email	kenkojim@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural Univerisity of Medicine
Institute
Department

Funding Source
Organization	Bayer
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 16 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	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 01 Day
Date of IRB	2017 Year 02 Month 23 Day
Anticipated trial start date	2017 Year 02 Month 24 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry	2020 Year 01 Month 31 Day
Date trial data considered complete	2020 Year 02 Month 28 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information	none

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2020 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030071