UMIN-CTR Clinical Trial

Public title

The Correlation for Improvement of Visual Acuity and QOL after Ranibizumab Treatment for Age-Related Macular Degeneration Patients

Acronym

QUATRO Study

Scientific Title

The Correlation for Improvement of Visual Acuity and QOL after Ranibizumab Treatment for Age-Related Macular Degeneration Patients

Scientific Title:Acronym

QUATRO Study

Region

Japan

Condition

Age-related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the relationship of the effect between visual acuity improvement and QOL improvement before and after ranibizumab treatment. Intravitreous ranibizumab injection is performed consecutive 3 times every one month in patients with age-related macular degeneration, and best-corrected visual acuity and VFQ-25 are measured 3 months later.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Baseline change of best-corrected visual acuity (LogMAR) and QOL (VFQ-25) 3 months after ranibizumab administration.

Key secondary outcomes

1) Baseline change of best-corrected visual acuity (LogMAR) just before and 12 months after ranibizumab administration.
2) Baseline change of QOL (VFQ-25) just before and 12 months after ranibizumab administration.
3) Baseline change of central retinal thickness by OCT examination just before, 3 months and 12 months after ranibizumab administration.
4) Patient rate of exudative change (subretinal fluid, retinal edema and serous retinal pigment epithelial detachment) just before, 3 months and 12 months after ranibizumab administration.
5) Baseline change of greatest linear dimension just before, 3 months and 12 months after ranibizumab administration.
6) Baseline change of patient satisfaction questionnaire just before, 3 months and 12 months after ranibizumab administration.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Ranibizumab (genetical recombination): Lucentis is 0.5 mg given monthly as a single intravitreal injection. This
corresponds to an injection volume of 0.05 ml.Treatment is given consecutive 3 times every one month as the induction period. In the later maintenance period, dose intervals are appropriately controlled by the patient symptoms, but the dose intervals are left more than 1 month.

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

50

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with age-related macular degeneration accompanied by exudative change by FA, ICGA or OCT examination.
2) Best-corrected visual acuity (decimal point visual acuity) of subject eye is more than 0.05.
3) Both genders at more than 50 years old.
4) Patients providing written informed consent.

Key exclusion criteria

1) Patients whose lesion site evaluated by FA examination is more than 12 optic disc areas (1 optic disc area is 30.5mm2, a lesion including a bleeding, scar and neo-vascularization) in subject eye.
2) Patient with a scar or fibrosis in the range more than 50% of all lesions in subject eye.
3) Patients with a history of retinal pigment epithelium tear or rupture in subject eye.
4) Patients with a history of more than stage 3 macular hole in subject eye.
5) Patients with treatment of triamcinolone intravitreal injection within 6 months in subject eye.
6) Patient with a history of intraocular surgical operation (including cataract) within 3 months in subject eye.
7) Patient with a history of surgical operation such as vitrectomy and submacular surgery in subject eye.
8) Patients with intraocular, extraocular and periocular inflammation or infectious in either eye.
9) Patients with a history of uveitis in either eye.
10) Patients with serious allergic history to such as fluoresceine, indocyanine green, iodo.
11) Women who have pregnancy, possibility of the pregnancy or are nursing.
12) Any other patients who are regarded as unsuitable for this study by the investigators

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Tatsuro Ishibashi

Organization

Kyushu University Graduate School of Medical Sciences

Division name

Department of Ophthalmology

Zip code

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka-city, Fukuoka, Japan

TEL

092-642-5648

Email

ishi@eye.med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yuji Oshima

Organization

Kyushu University Graduate School of Medical Sciences

Division name

Department of Ophthalmology

Zip code

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka-city, Fukuoka, Japan

TEL

092-642-5648

Homepage URL

Email

yuji@eye.med.kyushu-u.ac.jp

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name

Organization

Novartis Pharma K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

九州大学病院（福岡県）、福岡大学病院（福岡県）、久留米大学病院（福岡県）、産業医科大学病院（福岡県）

Date of disclosure of the study information

2013

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

10

Month

02

Day

Date of IRB

Anticipated trial start date

2013

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

10

Month

10

Day

Last modified on

2016

Year

12

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014037