UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013240
Receipt number R000015450
Scientific Title The effect of intravitreal ranibizumab on systemic hypertension in age-related macular degeneration patients with hypertension.
Date of disclosure of the study information 2014/02/27
Last modified on 2014/02/24 16:36:45

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Basic information

Public title

The effect of intravitreal ranibizumab on systemic hypertension in age-related macular degeneration patients with hypertension.

Acronym

The effect of intravitreal ranibizumab on systemic hypertension in age-related macular degeneration patients with hypertension.

Scientific Title

The effect of intravitreal ranibizumab on systemic hypertension in age-related macular degeneration patients with hypertension.

Scientific Title:Acronym

The effect of intravitreal ranibizumab on systemic hypertension in age-related macular degeneration patients with hypertension.

Region

Japan


Condition

Condition

age-related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the effect of intravitreal ranibizumab administration on systemic blood pressure levels in hypertensive patients with systolic blood pressure of >140mmHg and diastolic blood pressures of >90mmHg (grade 1 hypertension according to WHO-ISH)

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

systemic blood pressure

Key secondary outcomes



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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with age related macular degeneration and hypertension (systolic blood pressure of >140mmHg and diastolic blood pressure of >90mmHg at baseline measurement), planned to receive treatment with intravitreal ranibizumab at Tokushima University Hospital.

Key exclusion criteria

Patients refused entry into the study.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinori Mitamura

Organization

Institute of Health Biosciences, The University of Tokushima Graduate School

Division name

Department of Ophthalmology

Zip code


Address

3-18-15, Kuramoto-cho, Tokushima 770-8503, Japan

TEL

088-633-7163

Email

katome@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Katome

Organization

Institute of Health Biosciences, The University of Tokushima Graduate School

Division name

Department of Ophthalmology

Zip code


Address

3-18-15, Kuramoto-cho, Tokushima 770-8503, Japan

TEL

088-633-7163

Homepage URL


Email

katome@tokushima-u.ac.jp


Sponsor or person

Institute

Institute of Health Biosciences, The University of Tokushima Graduate School

Institute

Department

Personal name



Funding Source

Organization

Novartis

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 02 Month 27 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

Enrolling by invitation

Date of protocol fixation

2013 Year 11 Month 14 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 27 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Blood pressure measurements are performed in patients with age related macular degeneration and hypertension receiving intravitreal injection of ranibizumab, in every patient visits (just before first ranibizumab injection as baseline, month 1, 2, and 3).


Management information

Registered date

2014 Year 02 Month 24 Day

Last modified on

2014 Year 02 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015450


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name