UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014056
Receipt number R000016367
Scientific Title Evaluation of simplified treat and extend regimen using ranibizumab in exudative age related macular degeneration
Date of disclosure of the study information 2014/06/01
Last modified on 2019/03/08 18:26:33

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Basic information

Public title

Evaluation of simplified treat and extend regimen using ranibizumab in exudative age related macular degeneration

Acronym

Treat and exted regimen in exdative age related macular degeneration

Scientific Title

Evaluation of simplified treat and extend regimen using ranibizumab in exudative age related macular degeneration

Scientific Title:Acronym

Treat and exted regimen in exdative age related macular degeneration

Region

Japan


Condition

Condition

Age related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We evaluate the simplified treat and extend regimen using ranibizumab about best-corrected visual acuity, central retinal thickness, the disappearance rate of the morphological change and treatment continuous rate.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The change of best corrected visual acuity and central retinal thickness (at 12th and 24th months).

Key secondary outcomes

1:A drop-out rate of the third month and the twelfth month
2:The study continuance rate until 24 months


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Ranibizumab

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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects were eligible if the following criteria were met.
1) ability to provide written informed consent for this study
2) age>=50years old
3) intravitreal injection of ranibizumab as a first therapy for neovascular age-related macular degeneration (typical AMD and PCV)
4) best corrected visual acuity>=0.05

Key exclusion criteria

1) past intravitreal anti-VEGF therapy in the study eye
2) past intravitreal or subtenon injection of steroid therapy in the study eye
3) past vitrectomy therapy in the study eye
4) infection or suspicion of infection in eyes or periocular region
5) severe intraocular inflammation in eyes
6) past allergic reaction for ranibizumab
7) past allergic reaction for fluorescein, indocyanine green or iodine
8) pregnancy (positive pregnancy test) or lactating women
9) other conditions that the investigator believed would pose a significant hazard to the subject if investigational therapy were initiated.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mineo Kondo

Organization

Mie University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

2-174 Edobashi Tsu, Mie, Japan

TEL

059-232-1111

Email

ganka@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisashi Matsubara

Organization

Mie University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

2-174 Edobashi Tsu, Mie, Japan

TEL

059-232-1111

Homepage URL


Email

hmastu@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie University Graduate School of Medicine
Department of Ophthalmology

Institute

Department

Personal name



Funding Source

Organization

Novartis Pharma K.K

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

2014 Year 06 Month 01 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

Completed

Date of protocol fixation

2013 Year 11 Month 22 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 24 Day

Last modified on

2019 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016367


Research Plan
Registered date File name
2019/03/08 研究実施計画書簡易 .doc

Research case data specifications
Registered date File name
2019/03/08 データー仕様書.xlsx

Research case data
Registered date File name
2019/03/08 UMIN登録最終.xlsx