UMIN-CTR Clinical Trial

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

myopic choroidal neovascularization

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Ophthalmology of Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Novartis Pharma K.K. (Novartis Pharmaceuticals Japan)

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京医科歯科大学医学部附属病院（東京都文京区）

Date of disclosure of the study information

2015

Year

12

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2015

Year

12

Month

12

Day

Last modified on

2021

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=R000023281