UMIN-CTR Clinical Trial

Basic information
Public title	Long-term visual and anatomic outcome of intravitreal injection of ranibizumab for myopic choroidal neovascularization
Acronym	Long-term visual and anatomic outcome of intravitreal injection of ranibizumab for myopic choroidal neovascularization
Scientific Title	Long-term visual and anatomic outcome of intravitreal injection of ranibizumab for myopic choroidal neovascularization
Scientific Title:Acronym	Long-term visual and anatomic outcome of intravitreal injection of ranibizumab for myopic choroidal neovascularization
Region	Japan

Condition
Condition	myopic choroidal neovascularization
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the long-term visual outcome of myopic choroidal neovascularization (CNV) treated with intravitreal injection of ranibizumab (IVR) in 2-year follow-up.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of the best collected visual acuity(BCVA) at 2 years after IVR compared to the baseline in patients with myopic CNV.
Key secondary outcomes	1)Absolute BCVA value at 2 years 2)The rate of absence of dye leakage from CNV at 2 years after IVR 3)The number of IVR for 2 years 4)The number of CNV recurrence for 2-year period 5)The CNV size (every 6 months for 2 years) 6)The central retinal thickness (every 6 months for 2 years) 7)The subfoveal choroidal thickness (every 6 months for 2 years) 8)The subfoveal scleral thickness (every 6 months for 2 years) 9)The rate of developing CNV-related chorioretinal atrophy at 2 years after IVR 10)The size of CNV-related chorioretinal atrophy at 2 years after IVR 11)The prognostic factors for the mean change of BCVA at 2 years 12)The prognostic factors for loss of CNV activity (absence of dye leakage) at 2 years 13)The prognostic factors for the size of chorioretinal atrophy at 2 years 14)The patient satisfaction at 2 years compared to the baseline 15)The incidence rate of ocular and systemic adverse events 16)Based on the above data (1-15), we would like to establish the treatment guideline for up to 2 years for myopic CNV.

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	1) high myopia (axial length > 26.5 mm) 2) active CNV at the treatment (the presence of dye leakage on fluorescein angiogram) 3) a long-term follow-up of > 2 years after ranibizumab injection. The patients who participated in the RADIANCE study are also included in the study.
Key exclusion criteria	1) a history of other treatments for myopic CNV (PDT, other anti-VEGF reagents than ranibizumab) 2) a history of vitreoretinal surgery 3) a presence of other ocular complications which could affect the vision (dense cataract, foveal retinal detachment, macular holes, etc.
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Kyoko Middle name Last name Ohno-Matsui
Organization	Tokyo Medical and Dental University
Division name	Ophthalmology
Zip code	113-8510
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5302
Email	k.ohno.oph@tmd.ac.jp

Public contact
Name of contact person	1st name Yuka Middle name Last name Onishi
Organization	Tokyo Medical and Dental University
Division name	Ophthalmology
Zip code	113-8510
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5302
Homepage URL
Email	yuka0204@gmail.com

Sponsor
Institute	Ophthalmology of Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Novartis Pharma K.K. (Novartis Pharmaceuticals Japan)
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	Tokyo Medical and Dental University
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel	03-5803-5612
Email	tiken.crc@tmd.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	東京医科歯科大学医学部附属病院（東京都文京区）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 14 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	51
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	2015 Year 08 Month 25 Day
Date of IRB	2015 Year 09 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 14 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This is a retrospective study to analyze the clinical data of the patients with myopic CNV who had treatment with IVR between December 1 2010 and December 31 2013, and have been followed up at High Myopia Clinic of Tokyo Medical and ental University for at least 2 years. The patients have been followed regularly (at least every 6 months) for 2 years. Ocular examinations including OCT, fundus photos, fluorescein angiography, and fundus autofluorescence were regularly performed for all the patients. 1)patient demographics(at baseline) : age, gender, medical history 2)ocular demographics(at baseline) : refractive error(D), axial length(mm), presence of posterior staphyloma, types of posterior staphyloma 3)BCVA (at baseline and every 6 month) 4)fluorescein angiography(at baseline and every 6 month): CNV size, dye leakage from CNV 5)optical coherence tomography(OCT)(at baseline and every 6 month) : presence of serous retinal detachment, presence of intraretinal edema, presence of macular retinoschisis, the maximum height of CNV, the central retinal thickness, the subfoveal choroidal thickness, the subfoveal screal thickness 6)fundus autofluorescence(every 6 month) : presence of CNV-related atrophy, the size of CNV-related atrophy 7)vision-related QOL(NEI VFQ-25)(at 2 year) For controls, we have remarkably large series of historical controls who were followed up without any treatment for more than 5 years (around 100 patients). These patients were regularly followed at least every 6 months. The data of the historical controls are retrospectively analyzed and used to compare the outcome with ranibizumab-treated patients.

Management information
Registered date	2015 Year 12 Month 12 Day
Last modified on	2021 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=R000023281