UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030010
Receipt number R000034245
Scientific Title A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration
Date of disclosure of the study information 2017/11/22
Last modified on 2020/08/26 11:19:32

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Basic information

Public title

A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration

Acronym

A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration

Scientific Title

A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration

Scientific Title:Acronym

A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration

Region

Japan


Condition

Condition

Exudative age-related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of SJP-0133 compared to Lucentis in patients with exudative age-related macular degeneration

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in best-corrected visual acuity

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Three intravitreal injections of 0.05 mL SJP-0133 once every 4 weeks from the start of treatment to Week 8 followed by pro re nata injections of 0.05 mL SJP-0133 from Week 12 to Week 48.

Interventions/Control_2

Three intravitreal injections of 0.05 mL Lucentis once every 4 weeks from the start of treatment to Week 8 followed by pro re nata injections of 0.05 mL SJP-0133 from Week 12 to Week 48.

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

1. Written informed consent obtained after adequate explanation on participating the study
2. Japanese male or female outpatient, 50 years of age or older at consent
3. Presence of subfoveal choroidal neovascularization associated with exudative age-related macular degeneration

Key exclusion criteria

1. Presence of subfoveal subretinal haemorrhage
2. Presence of subfoveal fibrosis or atrophic
3. Presence of retinal pigment epithelial tear
4. Presence of choroidal neovascularization associated with any other disease
5. Presence of any other retinochoroidal disease that would affect the assessment of visual acuity
6. Presence of vitreous haemorrhage
7. Prior treatment with any anti-VEGF agents
8. History of surgical intervention for age-related macular degeneration
9. History of allergy or significant adverse drug reaction to any ingredients of drugs used in this study

Target sample size

338


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

TEL

059-231-5027

Email

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


Public contact

Name of contact person

1st name
Middle name
Last name Takuro Sekiya

Organization

Senju Pharmaceutical Co.,Ltd.

Division name

Clinical Development

Zip code


Address

6-4-3,Minatojima-Minamimachi,Chuo-Ku,Kobe,Hyogo,Japan

TEL

078-777-1018

Homepage URL


Email

t-sekiya@senju.co.jp


Sponsor or person

Institute

Senju Pharmaceutical Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

Senju Pharmaceutical Co.,Ltd.

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

2017 Year 11 Month 22 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

2017 Year 10 Month 19 Day

Date of IRB

2017 Year 10 Month 26 Day

Anticipated trial start date

2017 Year 11 Month 22 Day

Last follow-up date

2020 Year 02 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 11 Month 17 Day

Last modified on

2020 Year 08 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034245


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name