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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030010
Receipt No. 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 2018/11/19

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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
Institute Senju Pharmaceutical Co.,Ltd.
Institute
Department

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 Open public recruiting
Date of protocol fixation
2017 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 22 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
2017 Year 11 Month 17 Day
Last modified on
2018 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.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


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